Revivehills by Herbal Hills

POSSIBLY EFFECTIVE

• Anxiety. Small clinical studies suggest that oral ashwagandha might reduce anxiety. Details: One small clinical study in postal workers reporting moderate or severe anxiety shows that taking ashwagandha root (Swiss Herbals) 300 mg twice daily for 12 weeks, in combination with standard psychotherapy interventions, including dietary counseling, deep breathing exercise instruction, and a multivitamin, reduces anxiety scores when compared with standard psychotherapy interventions and placebo (19271). Additionally, two small clinical studies in adults with mild to moderate anxiety, depression, or stress show that taking a specific ashwagandha root extract standardized to contain 2.5% withanolides (Shagandha, Sabinsa Corp.) 500 mg with piperine 5 mg daily for 60-90 days reduces anxiety symptoms and perceived stress and improves sleep and quality of life when compared with placebo (113608,113609). However, another clinical study in young adults shows that taking a specific ashwagandha root and leaf extract (NooGandha, Specnova LLC) 225 mg or 400 mg daily for 30 days does not improve anxiety, stress, and depression scores when compared with placebo (107370).
• Generalized anxiety disorder (GAD). Oral ashwagandha may modestly improve symptoms of anxiety in patients with GAD. Details: Clinical practice guidelines from the World Federation of Societies of Biological Psychiatry (WFSBP) and the Canadian Network for Mood and Anxiety Treatments (CANMAT) provisionally recommend ashwagandha root extract at doses of 300-600 mg, standardized to 5% withanolides, daily as monotherapy or adjunctive therapy in patients with GAD. This recommendation is based on a review of three preliminary clinical trials with consistent results (110318). Two of these studies are described below. A small clinical trial in patients with GAD who are taking selective serotonin reuptake inhibitors (SSRIs) shows that taking ashwagandha 1 gram daily for 6 weeks reduces symptoms of anxiety by 48%, compared with a 27% reduction in patients taking placebo. Furthermore, by the end of treatment, 72% of patients taking ashwagandha were determined to have mild symptoms of GAD, compared with only 32% of those taking placebo (102687). Another preliminary clinical trial in patients aged 16 years and older with GAD shows that taking ashwagandha root powder granules 4 grams three times daily for 60 days moderately improves anxious mood in 58% of patients, compared with no moderate improvement in the placebo group. Mild improvement occurred in 82% of patients in the placebo group and 40% of patients in the ashwagandha group (90654).
• Insomnia. Oral ashwagandha may modestly improve sleep in patients with insomnia or non-restorative sleep. Details: A small meta-analysis in patients with insomnia and healthy patients shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 250-600 mg daily or a specific root and leaf extract (Shoden, Arjuna Natural) 120 mg daily for 6-12 weeks modestly improves overall sleep, as well as sleep quality, sleep latency, total sleep time, wake time after sleep onset, and sleep efficiency, when compared with placebo. Effects were more pronounced in those with insomnia, with doses of at least 600 mg daily, and with treatment durations of at least 8 weeks (106784). These findings may be limited by heterogeneity of the included studies. In patients with non-restorative sleep, clinical research shows that taking a specific ashwagandha extract (Shoden, Arjuna Natural Private Ltd) 125 mg daily for 6 weeks increases sleep quality by 72%, compared with an improvement of 29% in patients taking placebo. Small to moderate improvements also occurred in total sleep time, sleep latency, and number of times awake (103476).
• Stress. Oral ashwagandha seems to help reduce stress and may also reduce stress-related weight gain. Details: A meta-analysis of seven small clinical studies in healthy adults, patients with chronic stress, or patients with psychiatric conditions shows that taking ashwagandha 240-1000 mg daily for 8-12 weeks improves stress when compared with placebo (109587). Clinical studies, some of which are included in the meta-analysis mentioned above, evaluating adults with chronic stress show that taking specific ashwagandha root extracts 240 mg daily (Shoden, Arjuna Natural Ltd.), 300 mg twice daily (KSM-66, Ixoreal Biomed), or 500 mg daily (Shagandha, Sabinsa Corp.) with piperine 5 mg for 60 days, or a specific slow-release capsule containing ashwagandha root extract (Prolanza) 300 mg daily for 90 days reduces perceived stress and cortisol levels when compared with baseline and placebo (90652,95617,101816,102682,107371,113608). Additionally, a small clinical study in adults with stress and a related comorbidity, such as anxiety or depression, shows that taking ashwagandha root and leaf extract (Sensoril, Kerry Group) 125-500 mg orally daily for 8 weeks improves stress scores in a dose-dependent manner when compared with placebo (114112). In contrast, a moderate-sized study in adults with overweight or mild obesity with moderate-to-high levels of stress and fatigue shows that taking ashwagandha root extract (Witholytin, Verdure Sciences Inc) 200 mg twice daily for 12 weeks reduces stress when compared to baseline, but not when compared with placebo (113611).In healthy college students, clinical research also shows that taking ashwagandha root extract 350 mg twice daily for 30 days improves qualitative perceptions of stress management, but not stress scores, when compared with placebo (109589,109590). Other clinical research shows that taking ashwagandha root extract 500 mg twice daily may prevent stress-related weight gain when compared with placebo (95617).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging. A small clinical study suggests that oral ashwagandha may modestly improve well-being, sleep, and alertness in elderly patients. Details: A small clinical trial in individuals aged 65-80 years shows that taking ashwagandha root extract (KSM-66, Ixoreal Biomed) 600 mg daily for 12 weeks improves overall well-being, sleep quality, and mental alertness by small to moderate amounts when compared with placebo (102684).
• Androgenic alopecia. It is unclear if topical ashwagandha is beneficial for androgenic alopecia. Details: A small clinical study in adults with mild to moderate hair loss, including androgenic alopecia, shows that applying ashwagandha root extract serum (KSM-66, Ixoreal Biomed) 1-2 drops to the scalp daily for 75 days reduces hair shedding and increases hair density, growth, and thickness when compared with placebo (113613).
• Antipsychotic-induced metabolic side effects. It is unclear if ashwagandha is beneficial for attenuating the metabolic side effects of antipsychotic agents. Details: One preliminary clinical trial shows that taking a specific ashwagandha extract (Cap Strelaxin, M/s Pharmanza Herbal Pvt. Ltd.) 400 mg three times daily for one month reduces serum triglycerides by 12% and fasting blood glucose by 15% when compared with baseline levels. Patients were taking atypical antipsychotics and had modestly elevated triglycerides and fasting blood glucose levels at baseline (90649). The validity of these findings is limited by the lack of a comparator group.
• Asthma. Although there has been interest in using oral ashwagandha for asthma, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Athletic performance. It is unclear if ashwagandha is beneficial for improving athletic performance. Details: A meta-analysis of four small clinical trials shows that taking ashwagandha increases aerobic capacity in athletes and non-athletes based on the measurement of maximum oxygen consumption. Effective doses ranged from 500-1000 mg daily for up to 12 weeks (102683). Another meta-analysis shows that taking ashwagandha in doses of 120-1250 mg daily, as a single dose or divided twice daily, for up to 6 months seems to improve muscle strength, speed, time to exhaustion, recovery time, and cardiorespiratory fitness in athletes and non-athletes (105824). However, the validity of this analysis is reduced by the lack of a control group, the varied training levels of the subjects, and the wide range of outcomes assessed. More research is needed to determine whether taking ashwagandha can improve athletic performance.
• Attention deficit-hyperactivity disorder (ADHD). Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In a preliminary clinical trial, children with ADHD were given a combination herbal extract formula (Nurture & Clarity), containing ashwagandha, white peony root, gotu kola, blue-green algae, bacopa, and sage, 3 mL three times daily for 4 months. Measures of attention, cognition, and impulse control improved significantly in children receiving ashwagandha when compared with placebo (19272). The dose of ashwagandha in the combination product was not reported, and the effect of ashwagandha alone in ADHD is unclear.
• Back pain. Although there has been interest in using oral or topical ashwagandha for back pain, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Bipolar disorder. It is unclear if oral ashwagandha is beneficial for improving cognitive function in adults with bipolar disorder. Details: Clinical research shows that taking ashwagandha extract (Sensoril, Natreon, Inc.) 250 mg daily for 1 week and then 250 mg twice daily for 7 weeks, improves some, but not all, measures of cognition by a small-to-moderate amount when compared with placebo (90653).
• Bronchitis. Although there has been interest in using oral ashwagandha for bronchitis, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Cerebellar ataxia. It is unclear if oral ashwagandha is beneficial for improving balance in patients with cerebellar ataxia. Details: A small, open-label study evaluating ashwagandha 500 mg three times daily in combination with Ayurvedic therapy for one month showed improvement in balance indices in subjects with cerebellar ataxia when compared with baseline (19273). The validity of this finding is limited by the lack of a comparator group. Additionally, it is unclear if this effect is due to ashwagandha, other ingredients, or the combination.
• Chemotherapy-related fatigue. Evidence is limited to one small clinical study in patients with breast cancer. Details: In preliminary clinical research in patients with breast cancer, taking ashwagandha powdered root extract 2 grams (Himalaya Drug Co) three times daily through six cycles of chemotherapy decreases chemotherapy-related fatigue when compared with no treatment. Fatigue scores were 16% to 52% higher in the control group when compared to the ashwagandha group (90651).
• Chronic obstructive pulmonary disease (COPD). It is unclear if oral ashwagandha is beneficial in patients with COPD. Details: A small clinical study in patients with stable COPD shows that taking ashwagandha root extract 250 mg twice daily for 12 weeks, along with conventional therapy, improves measures of lung function and exercise tolerance, but not quality of life, when compared with conventional therapy alone (109588).
• Cognitive function. Although there has been interest in using oral ashwagandha for cognitive function, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Constipation. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A very small clinical study in adults with constipation shows that taking a combination product containing ashwagandha root and ambrette fruit extracts 300 mg or 500 mg daily for 14 days improves bowel movement frequency and abdominal, rectal, and stool symptoms when compared with placebo (112114). Additionally, a moderate-sized clinical study in adults with functional constipation shows that using the same combination of ashwagandha and ambrette 300 mg or 500 mg daily for 60 days moderately improves constipation symptom scores and bowel movement scores when compared with placebo (114115). It is unclear if these effects are due to ashwagandha, ambrette, or the combination.
• Coronavirus disease 2019 (COVID-19). Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults hospitalized with COVID-19 shows that taking a specific combination product, (Artovid-20, Bioved Pharmaceuticals) containing ashwagandha, ginger, turmeric, and Boswellia, 1,776 mg orally twice daily for 14 days shortens the duration of symptoms by 0.9 days when compared with placebo. Taking the combination product also modestly reduced the severity ratings of some symptoms, such as sore throat and cough, however, these improvements are unlikely to be clinically relevant (109899). Another small clinical study in adults with mild to moderate COVID-19 shows that taking ashwagandha 500 mg and ginger 1000 mg twice daily for 15 days reduces time to recovery by around 6 days and increases the rate of clinical cure 14-fold and 2.6-fold at days 5 and 7, respectively, when compared with a control. However, taking this combination does not appear to improve the proportion of patients with a negative COVID-19 test, viral clearance, serum antibodies, chest findings, or disease progression when compared with control (112094). The validity of these findings is limited by a lack of blinding, and the study may have been inadequately powered to detect a difference between groups. Other clinical research in adults hospitalized with mild to moderate COVID-19 shows that taking a specific combination product (Coroprotect) containing ashwagandha, pomegranate, turmeric, bacopa, licorice, and other ingredients, twice daily for 10 days improved cough, breathlessness, and fatigue symptoms when compared with placebo (114114). It is unclear if any effects are due to ashwagandha, other ingredients, or the combination.
• Depression. It is unclear if oral ashwagandha is beneficial for depression. Details: A small clinical study in adults with mild to moderate depression, anxiety, or stress shows that taking a specific ashwagandha root extract standardized to contain 2.5% withanolides (Shagandha, Sabinsa) 500 mg with piperine 5 mg daily for 90 days reduces the severity of depressive symptoms, improves sleep and quality of life, and increases serum serotonin levels when compared with placebo (113609).
• Diabetes. It is unclear if oral ashwagandha is beneficial for type 2 diabetes. Details: In patients with type 2 diabetes, preliminary clinical research shows that ashwagandha 3 grams daily for 30 days decreases blood glucose to a degree similar to oral hypoglycemic drugs (19274). However, this study did not compare ashwagandha directly to a group taking oral hypoglycemic drugs.
• Fatigue. It is unclear if oral ashwagandha is beneficial for fatigue. Details: A moderate-sized clinical study in adults with overweight or obesity and moderate-to-high levels of fatigue and stress shows that taking ashwagandha root extract (Witholytin, Verdure Sciences Inc.) 200 mg twice daily for 12 weeks reduces self-reported fatigue when compared with placebo (113611).
• Fibromyalgia. Although there has been interest in using oral ashwagandha for fibromyalgia, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Hiccups. Although there has been interest in using oral ashwagandha for hiccups, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Hypercholesterolemia. It is unclear if ashwagandha is beneficial for hypercholesterolemia. Details: A very small clinical study in subjects with hypercholesterolemia shows that ashwagandha 3 grams daily for 30 days decreases serum cholesterol, triglyceride, low-density lipoprotein (LDL) cholesterol, and very low-density lipoprotein (VLDL) cholesterol levels when compared with baseline (19274). The validity of these findings is limited by the lack of a comparator group.
• Hypothyroidism. It is unclear if ashwagandha is beneficial for hypothyroidism. Details: Preliminary clinical research in adults with subclinical hypothyroidism shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily for 8 weeks increases triiodothyronine (T3) and thyroxine (T4) levels by 42% and 20%, respectively, and reduces serum TSH levels by 17% from baseline. These changes are significant when compared with placebo (97292). However, the effects of ashwagandha on thyroid hormone levels in patients with overt hypothyroidism, or in patients taking prescription thyroid hormones, is unknown.
• Infertility. Although there has been interest in using oral ashwagandha for infertility in females, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Male infertility. It is unclear if oral ashwagandha is beneficial for male infertility. Details: Preliminary clinical research in males with infertility shows that taking ashwagandha root powder for approximately 3 months modestly improves hormone levels, as well as sperm count and motility, when compared with baseline (19275,90650). The validity of these findings is limited by the lack of a comparator group. One study used a specific ashwagandha root extract (KSM-66 Ashwagandha, Ixoreal Biomed) 225 mg three times daily; another study provided doses of 5 grams daily (19275,90650).
• Menopausal symptoms. Oral ashwagandha may be beneficial for menopausal symptoms. Details: A small clinical study in healthy adults in perimenopause shows that taking a specific ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily for 8 weeks improves menopausal symptom severity by 24%, compared with 11% in those receiving placebo. Quality of life and hot flashes also were improved in those taking ashwagandha (106785).
• Obsessive-compulsive disorder (OCD). It is unclear if ashwagandha is beneficial for OCD. Details: Preliminary clinical research shows that taking ashwagandha root extract 120 mg after meals for 6 weeks, in conjunction with prescribed selective-serotonin reuptake inhibitors (SSRIs), might reduce OCD symptom severity when compared with prescribed SSRIs alone. The dose was initiated at 30 mg daily and increased by 30 mg every 4 days. Although OCD scores were significantly reduced when compared with placebo, it should be noted that scores were already significantly lower in the placebo group at baseline (95618).
• Osteoarthritis. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with osteoarthritis, taking a specific combination supplement, containing ashwagandha 450 mg, Ayurvedic zinc complex 50 mg, guggul 100 mg, and turmeric 50 mg (Articulin-F) two capsules three times daily for 3 months reduces symptoms of pain and swelling when compared with placebo. However, there were no radiological improvements (19276). It is unclear if this effect is due to ashwagandha, other ingredients, or the combination.
• Parkinson disease. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In patients with Parkinson disease, a small clinical study shows that taking a product containing ashwagandha 14.5 grams, cowhage 4.5 grams, Hyoscyamus reticulantus 0.75 grams, and Sida cordifolia 14.5 grams in lukewarm milk twice daily for 56 days improves symptoms like tremor, stiffness, and cramps when compared with baseline. The therapy followed 28 days of cleansing or eliminative therapy using Ayurvedic remedies (6899). The validity of these findings is limited by the lack of a comparator group. Also, it is unclear if these effects are due to ashwagandha, other ingredients, or the combination. Cowhage contains levodopa, which may contribute to any benefit seen with this combination product.
• Psychological well-being. It is unclear if oral ashwagandha is beneficial for improving psychological well-being in college students. Details: A small clinical study in healthy college students shows that taking ashwagandha root extract 350 mg twice daily for 30 days improves perceptions of well-being, including improvements in energy, mental clarity, food cravings, and sleep quality, when compared with placebo. Qualitative analysis also suggests these students had improvements in stress management, but stress scores were not reduced when compared with placebo (109589,109590).
• Rheumatoid arthritis (RA). It is unclear if ashwagandha is beneficial for improving symptoms of RA. Details: Preliminary clinical research shows that taking ashwagandha powder 5 grams twice daily for 3 weeks, followed by 4 weeks of sidh makardhwaj (a mixture of gold, mercury, and sulfur) 100 mg with honey daily, modestly improves symptoms in about 50% of males and 60% of females with RA when compared with baseline (95620). The lack of a control group limits the validity of this finding. Additionally, the effect of ashwagandha powder alone is unclear.
• Sexual dysfunction. Small clinical studies suggest that oral ashwagandha root extract may help improve sexual arousal and sexual desire in some females and males with sexual dysfunction. Details: Two, small clinical studies in adult females with sexual dysfunction show that taking ashwagandha root extract (KSM-66, Ixoreal Biomed) 300 mg twice daily with food for 8 weeks in conjunction with or without counseling increases the number of successful sexual encounters and improves orgasms, satisfaction, lubrication, and arousal when compared with placebo or counseling alone (95619,110492). Also, a small clinical study in adult males with low sexual desire shows that taking the same ashwagandha root extract 300 mg twice daily after meals for 8 weeks improves subjective sexual functioning scores, including measures of sexual arousal, sexual desire, sexual behavior, and orgasm, when compared with placebo (109586).
• Smoking cessation. Oral ashwagandha has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A moderate-sized clinical study in adults with a history of smoking 5 or more cigarettes daily for at least 3 years shows that taking a specific combination product containing ashwagandha 100 mg, Indian gooseberry, tribulus, bacopa, Albizia lebbeck, licorice, clove, ginger, cowhage, holy basil, and turmeric (Smotect, Smotect India) daily for 3 months reduces the number of cigarettes smoked daily and levels of alveolar carbon monoxide and carboxyhemoglobin but does not improve lung capacity when compared with placebo (112115). It is unclear if these effects are due to ashwagandha, other ingredients, or the combination.
• Tuberculosis. Although there has been interest in using oral ashwagandha for tuberculosis, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Vitiligo. Although there has been interest in using oral ashwagandha for vitiligo, there is insufficient reliable information about the clinical effects of ashwagandha for this condition.
• Wrinkled skin. It is unclear if topical ashwagandha is beneficial in individuals with wrinkled skin. Details: A small clinical study in healthy adults with photoaged skin shows that applying ashwagandha root extract 8% lotion daily for 60 days improves physician-rated scores for skin wrinkles, hydration, brightness, tone, and pigmentation and improves other measures of skin elasticity and hydration when compared with placebo. However, changes in melanin content did not differ between treatment groups (111538).
• Wound healing. Although there has been interest in using topical ashwagandha for healing of skin ulcers and skin sores, there is insufficient reliable information about the clinical effects of ashwagandha for this condition. More evidence is needed to rate ashwagandha for these uses.

(Read more about ASHWAGANDHA)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Anxiety. Although there has been interest in using oral cowhage for anxiety, there is insufficient reliable information about the clinical effects of cowhage for this purpose.
• Erythema. Although there has been interest in using topical cowhage for erythema, there is insufficient reliable information about the clinical effects of cowhage for this purpose.
• Hyperprolactinemia. Although there has been interest in using oral cowhage for hyperprolactinemia, there is insufficient reliable information about the clinical effects of cowhage for this purpose.
• Myalgia. Although there has been interest in using topical cowhage for myalgia, there is insufficient reliable information about the clinical effects of cowhage for this purpose.
• Parkinson disease. It is unclear if oral cowhage is beneficial in patients with Parkinson disease. Details: Very small clinical studies in patients with Parkinson disease suggest that taking a specific cowhage seed extract standardized to 3.3% levodopa (Zandopa, formerly HP-200; Zandu Pharmaceuticals), or other cowhage products that contain levodopa 75-400 mg orally once daily for up to 12 weeks modestly improves Parkinson disease scores when compared with baseline (7020,7203). Two very small clinical trials enrolling a total of 26 patients with Parkinson disease suggests that taking a single dose of cowhage powder, providing levodopa 1000-2000 mg or 12.5-17.5 mg/kg, is similarly effective after 90 minutes when compared with prescription levodopa 200 mg or 3.5 mg/kg as a single dose, with or without carbidopa and benserazide (12232,97266). It is unclear how these products would compare if they provided similar amounts of levodopa, or if they were taken for an extended duration.
• Rheumatoid arthritis (RA). Although there has been interest in using topical cowhage for RA, there is insufficient reliable information about the clinical effects of cowhage for this purpose.
• Sexual desire. Although there has been interest in using oral cowhage to increase sexual desire, there is insufficient reliable information about the clinical effects of cowhage for this purpose. More evidence is needed to rate cowhage for these uses.

(Read more about COWHAGE)

POSSIBLY EFFECTIVE

• Dyslipidemia. Oral Indian gooseberry seems to be beneficial for dyslipidemia. Details: Meta-analyses of 12 small clinical studies in healthy adults or patients with dyslipidemia, diabetes, hypertension, or metabolic syndrome show that taking Indian gooseberry fruit extract or powder 0.5-3 grams daily or Indian gooseberry fruit 12 grams daily for 2-12 weeks reduces total cholesterol by around 39 mg/dL, low-density lipoprotein (LDL) cholesterol by around 15-34 mg/dL, and triglycerides by around 22-52 mg/dL when compared with control groups. Results are conflicting whether Indian gooseberry increases high-density lipoprotein (HDL) cholesterol (111567,111568). Subgroup analysis suggests that Indian gooseberry is more effective at doses greater than 1 gram daily and in adults with triglycerides above 150 mg/dL (111568). Clinical research in patients with dyslipidemia shows that taking Indian gooseberry whole fruit extract (Tri-low, Arjuna Natural Ltd.) 500 mg twice daily for 12 weeks reduces triglyceride and low-density lipoprotein (LDL) cholesterol levels by 34% and 20%, respectively, compared with 15% and 5%, respectively, in patients taking placebo (99238).
• Gastroesophageal reflux disease (GERD). Oral Indian gooseberry seems to be beneficial for reducing symptoms of GERD. Details: Clinical research in adults who have had non-erosive symptoms of GERD for at least 3 months shows that taking Indian gooseberry fruit extract 1000 mg twice daily for 4 weeks reduces the frequency and severity of heartburn and regurgitation by about 63% and 50%, respectively, compared with reductions of 24% and 5%, respectively, in patients taking placebo (99240).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Aging skin. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in healthy, middle-aged females shows that drinking 50 mL of a juice containing Indian gooseberry extract 30-60 mg and lingonberry extract 25-50 mg daily for 12 weeks improves skin elasticity, thickness, wrinkles, and hydration when compared with placebo (102856). It is unclear if these effects are due to Indian gooseberry, lingonberry, or the combination. Another small clinical study in healthy, middle-aged females shows that applying a topical emulsion containing extracts of Indian gooseberry 3% and gotu kola 3% twice daily for 60 days improves skin hydration, some measures of skin wrinkles, and elasticity of the cheek but not the eye when compared with placebo (111571). It is unclear if these effects are due to Indian gooseberry, gotu kola, or the combination.
• Androgenic alopecia. Topical Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In individuals with self-perceived hair loss, preliminary clinical research shows that applying a hair product containing Indian gooseberry modestly improves hair growth rate and density, as well as hair thinning, when compared with baseline. Patients used a leave-in product containing Indian gooseberry (Saberry), coconut water solids (Cococin), gamma-L-glutamyl-selenomethionine (Peptiselect), and other ingredients as 3.5 mL in females and 2 mL in males, once daily for 3 months (105353).
• Cancer. Although there is interest in using oral Indian gooseberry for cancer, there is insufficient reliable information about the clinical effects of Indian gooseberry for this purpose.
• Cardiovascular disease (CVD). It is unclear if oral Indian gooseberry is beneficial for the prevention of CVD. Details: A meta-analysis of 9 small clinical studies in adults who are healthy or have CVD risk factors shows that taking Indian gooseberry fruit extract or powder 500-1500 mg daily for 2-12 weeks reduces low-density lipoprotein (LDL) cholesterol by around 15 mg/dL, very low-density lipoprotein (VLDL) cholesterol by around 5 mg/dL, triglycerides by around 22 mg/dL, and high-sensitivity C-reactive protein when compared with control groups. However, the meta-analysis suggests that Indian gooseberry does not improve high-density lipoprotein (HDL) cholesterol, systolic blood pressure, or diastolic blood pressure (111567). The validity of these findings is limited by small sample sizes and considerable heterogeneity among the included studies.
• Coronavirus disease 2019 (COVID-19). It is unclear if oral Indian gooseberry is beneficial for the treatment of COVID-19 in hospitalized adults. Details: A small clinical trial in adults hospitalized with COVID-19 shows that receiving Indian gooseberry powder 2 grams twice daily for 10 days does not impact RT-PCR positivity rate at day 10 when compared with placebo. Additionally, there were no clear trends in clinical improvement in patients receiving Indian gooseberry when compared with placebo. All patients in this study also received oral hydroxychloroquine and lopinavir/ritonavir (110012).
• Diabetes. Several small or limited-quality clinical studies suggest that oral Indian gooseberry may modestly improve glycemic control and blood lipid levels in patients with type 2 diabetes. Details: A moderate-sized, open-label study in adults with newly-diagnosed type 2 diabetes and dyslipidemia shows that taking Indian gooseberry extract, standardized to 10% beta-glucogallin, 2 grams daily for 90 days reduces glycated hemoglobin (HbA1c), fasting blood glucose, and postprandial blood glucose when compared to baseline, with superior effects on fasting blood glucose and postprandial blood glucose when compared with metformin 500 mg (111569). A smaller clinical study in patients with type 2 diabetes on stable doses of metformin shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc) 500 mg twice daily for 12 weeks reduces HbA1c by around 0.5% and improves low-density lipoprotein (LDL) cholesterol, triglyceride, and high-density lipoprotein (HDL) levels when compared with placebo. Taking a lower dose, 250 mg twice daily, does not seem to improve HbA1c but has a modest effect on lipid levels (105356). Another small clinical study in patients with type 2 diabetes using various antidiabetes drugs shows that taking powdered Indian gooseberry fruit 1 gram, 2 grams, or 3 grams daily for 3 weeks modestly reduces fasting and 2-hour postprandial blood glucose levels and improves lipid levels when compared to baseline (105355). The validity of these findings is limited by the lack of a comparator group.
• Hangover. It is unclear if oral Indian gooseberry is beneficial for hangover prevention. Details: A small clinical trial shows that taking Indian gooseberry leaf extract (Phyllpro) 750 mg daily for 10 days prior to alcohol intoxication modestly reduces some hangover symptoms 10 hours later, including nausea, headache, lack of appetite, and dizziness, when compared with placebo. Blood alcohol levels after 12 hours were also reduced. However, the overall hangover score was not significantly different between groups (99846).
• Hepatitis B. Although there is interest in using oral Indian gooseberry for hepatitis B, there is insufficient reliable information about the clinical effects of Indian gooseberry for this condition.
• Hypercholesterolemia. Small studies suggest that oral Indian gooseberry might help to reduce low-density lipoprotein (LDL) cholesterol levels. Details: Preliminary clinical research shows that taking Indian gooseberry might reduce levels of LDL cholesterol in patients with hypercholesterolemia. One preliminary clinical study shows that taking Indian gooseberry 50 grams for 4 weeks decreases LDL cholesterol by 15% when compared to baseline (2077). Other preliminary clinical research shows that taking Indian gooseberry fruit extract (Amlamax, Arjuna Natural Ltd.) 500 mg or 1000 mg daily for 6 months reduces levels of LDL cholesterol by about 13% when compared with baseline (99241). Also, one small study shows that taking an Indian gooseberry fruit juice powder 500 mg daily for 6 weeks modestly decreases LDL cholesterol and triglyceride levels when compared with baseline (99242). Some preliminary clinical research also shows that Indian gooseberry reduces LDL cholesterol in obese individuals. One small study shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc.) 500 mg twice daily for 12 weeks reduces LDL cholesterol by 16 mg/dL in this population when compared to baseline (92515). However, the validity of these studies is limited by the lack of comparator groups.
• Hypertension. It is unclear if oral Indian gooseberry is beneficial for hypertension. Details: In patients with uncontrolled hypertension using standard therapies, clinical research shows that taking Indian gooseberry dried fruit powder 500 mg three times daily for 8 weeks reduces systolic blood pressure (SBP) and diastolic blood pressure (DBP) by 16% and 12%, respectively, from baseline, which is significantly greater than reductions seen with placebo. The frequency of response to treatment, based on a reduction in SBP or DBP of at least 10 mmHg or 5 mmHg, respectively, was also increased from up to 50% to at least 83% of patients (105352). However, other clinical research in adults with cardiovascular risk factors shows that taking Indian gooseberry 500-1500 mg twice daily for 2-12 weeks does not reduce SBP or DBP more than placebo (105354,111567).
• Irritable bowel syndrome (IBS). Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small, open-label study of adults with IBS shows that taking 7 grams of an Unani medicinal product called Jawarish Shahi, containing Indian gooseberry, terminalia, coriander, cardamom, and willow bark, twice daily for 45 days reduces the severity of IBS, as measured by improvements in abdominal pain and distension, bowel habits, and quality of life, when compared to baseline (111570). The validity of these findings is limited by insufficient blinding and the lack of a comparator group. It is unclear if these effects are due to Indian gooseberry, other ingredients, or the combination.
• Metabolic syndrome. It is unclear if oral Indian gooseberry is beneficial for metabolic syndrome. Details: Preliminary clinical research in adults with metabolic syndrome shows that taking a specific Indian gooseberry extract (Capros, Natreon Inc.) 250 mg twice daily for 12 weeks reduces total cholesterol by nearly 10%, low-density lipoprotein (LDL) cholesterol by 15%, and triglycerides by 10%, and increases high-density lipoprotein (HDL) cholesterol by about 7% when compared with placebo. Additionally, taking this product as 500 mg twice daily reduces total cholesterol by 14%, LDL cholesterol by 26%, and triglycerides by 19%, and increases HDL cholesterol by 22% when compared with placebo. Both doses also seem to improve markers of endothelial function, oxidative stress, and systemic inflammation (102857).
• Obesity. It is unclear if oral Indian gooseberry is beneficial for improving weight loss or metabolic parameters in adults with obesity. Details: Preliminary clinical research in overweight or obese individuals shows that taking Indian gooseberry fruit extract (Capros, Natreon Inc.) 500 mg twice daily for 12 weeks reduces low-density lipoprotein (LDL) cholesterol by 16 mg/dL when compared to baseline. However, there was no effect on other lipids or on blood pressure, body weight, or body mass index (92515). The validity of these findings is limited by the lack of a comparator group.
• Oral mucositis. It is unclear if oral Indian gooseberry is beneficial in patients with radiation-induced mucositis. Details: A retrospective observational study in patients with head and neck cancer receiving radiotherapy suggests that rinsing the mouth with Indian gooseberry 1% and povidone-iodine twice daily is associated with delayed development of mucositis and intolerable mucositis and a decreased incidence of intolerable mucositis when compared with povidone-iodine alone (111566). The validity of these findings is limited by the retrospective study design.
• Osteoarthritis. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with knee osteoarthritis suggests that specific Ayurvedic formulas containing Indian gooseberry may be equivalent to glucosamine sulfate 2 grams daily or celecoxib 200 mg daily for reducing pain. Two capsules containing Indian gooseberry 166.66 mg/capsule, ginger 33.33 mg/capsule, and Tinospora cordifolia 73.33 mg/capsule, with or without Boswellia serrata 100 mg/capsule, taken three times daily for 24 weeks, were used. All four treatments reduced active pain by about 28% to 38%, functional pain by 19% to 29%, and functional difficulty by 18% to 25%, with no significant between-group differences in the observed improvements (89557). It is not clear if these effects are due to Indian gooseberry, the other ingredients, or the combination.
• Periodontitis. It is unclear if subgingival Indian gooseberry is beneficial for periodontitis. Details: Clinical research in patients with chronic periodontitis shows that the subgingival application of a sustained-release Indian gooseberry fruit 10% gel following scaling and root planing does not affect plaque or gingivitis development over 2-3 months when compared with placebo. However, there was a modest benefit on periodontal destruction based on probing pocket depth (105358).
• Vitiligo. Oral Indian gooseberry has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with vitiligo shows that taking 1 tablet containing Indian gooseberry 100 mg, vitamin E 10 mg, and carotenoids 4.7 mg orally 3 times daily for 6 months, in combination with conventional topical therapy and/or phototherapy, increases re-pigmentation in the head, neck, and trunk and decreases signs of inflammation when compared with conventional treatment alone (92513). More evidence is needed to rate Indian gooseberry for these uses.

(Read more about INDIAN GOOSEBERRY)

POSSIBLY EFFECTIVE

• Alcohol use disorder. Oral kudzu seems to be beneficial for reducing alcohol consumption in heavy drinkers; however, it may not be beneficial in those with chronic alcohol use disorder. Details: Some research shows that heavy drinkers who take a specific kudzu root extract (Alkontrol-Herbal; NPI-031; Natural Pharmacia International, Inc.) 0.5-1 grams three times daily for 1-4 weeks consume less beer when given an opportunity to drink and may have more abstinent days (13085,92257). Other research shows that binge drinkers who take kudzu extract 2 grams as a single dose 2.5 hours prior to a 90-minute binge drinking episode consume 37% fewer beers than those taking placebo (92258). However, kudzu does not seem to decrease the craving for alcohol (10386,13085,57948,92257). Kudzu extract also does not seem to improve sobriety in people with chronic alcohol use disorder (10386).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). Although there is interest in using oral kudzu for allergic rhinitis, there is insufficient reliable information about the clinical effects of kudzu for this condition.
• Angina. Although there is interest in using the injectable kudzu constituent puerarin for angina, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
• Angioplasty. Although there is interest in using the injectable kudzu constituent puerarin in patients undergoing percutaneous transluminal coronary angioplasty (PTCA), there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
• Athletic performance. Oral kudzu has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in healthy males shows that taking capsules containing kudzu isoflavone extract 180 mg, soybean peptides 600 mg, taurine 200 mg, and ginseng saponins 120 mg daily in two divided doses for 15 days can significantly increase time to exhaustion during exercise when compared with placebo (57945).
• Back pain. Although there is interest in using the injectable kudzu constituent puerarin for back pain, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
• Cluster headache. Although there is interest in using oral kudzu for cluster headache, there is insufficient reliable information about the clinical effects of kudzu for this condition.
• Coronary heart disease (CHD). Although there is interest in using the injectable kudzu constituent puerarin for CHD, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
• Diabetes. It is unclear if oral kudzu is beneficial for diabetes. Details: Preliminary clinical research in adults with type 2 diabetes shows that taking oral puerarin, a kudzu constituent, 250 mg three times daily in addition to rosiglitazone 4 mg daily for 12 weeks reduces blood glucose levels and glycated hemoglobin (HbA1c) when compared to baseline (57951). The effect of kudzu alone is unclear. Additionally, the lack of a comparator group limits the validity of this finding.
• Diabetic nephropathy. It is unclear if oral kudzu is beneficial for diabetic nephropathy. Details: Preliminary clinical research in patients with diabetic nephropathy shows that taking puerarin, a kudzu constituent, 250 mg three times daily in addition to rosiglitazone 4 mg daily for 12 weeks improves laboratory measurements of kidney function, including serum creatinine, blood urea nitrogen, and urinary albumin, when compared to baseline (57951). The effect of kudzu alone is unclear. Additionally, the lack of a comparator group limits the validity of this finding.
• Hangover. Although there is interest in using oral kudzu for hangover, there is insufficient reliable information about the clinical effects of kudzu for this condition.
• Heart failure. Although there is interest in using the kudzu constituent puerarin for heart failure, there is insufficient reliable information about the clinical effects of kudzu for this condition.
• Hypertension. It is unclear if oral kudzu is beneficial for hypertension. Details: Preliminary clinical research in adults with hypertension shows that taking kudzu powder 1.5 grams twice daily for 12 weeks decreases systolic blood pressure by 16% and diastolic blood pressure by 12% when compared to baseline (92261). The validity of this finding is limited by the lack of a comparator group.
• Menopausal symptoms. Small clinical studies suggest that oral kudzu may modestly improve menopausal symptoms. Details: Preliminary clinical research shows that taking kudzu 25 mg, 50 mg, or 100 mg daily for 6 months during perimenopause improves climacteric symptoms based on a modified Green climacteric scale when compared with baseline (57890,57942). Other preliminary clinical research in patients with menopausal symptoms shows that taking kudzu extract 0.84-2.52 grams daily for 4 weeks, providing puerarin 113-338 mg daily, modestly reduces overall menopausal symptoms when compared with baseline (108154). The validity of the findings from these studies is limited by the lack of a comparator group. Other clinical research shows that taking kudzu 50 mg daily for 6 months during perimenopause reduces vasomotor symptoms similarly to taking conjugated equine estrogen 0.625 mg with or without medroxyprogesterone acetate 2.5 mg daily (57927).
• Migraine headache. It is unclear if oral kudzu is beneficial for migraine headache. Details: Preliminary clinical research in adults with migraine shows that taking one capsule of kudzu (Kuzik) daily, providing an unspecified dose of kudzu, for 90 days reduces the number of headache attacks per month by about 3, with approximately 50% of patients achieving a 50% reduction in monthly headache days when compared with baseline. There were also modest improvements in disability and medication use (108155). The validity of these findings is limited by the lack of a comparator group.
• Myocardial infarction (MI). Although there is interest in using the injectable kudzu constituent puerarin for MI, there is insufficient reliable information about the clinical effects of oral kudzu for this condition.
• Obesity. It is unclear if oral kudzu is beneficial for obesity. Details: Preliminary clinical research in adults with obesity shows that taking a kudzu extract 300 mg daily for 12 weeks reduces visceral fat and body mass index (BMI) when compared with placebo. However, doses of 200 mg do not seem to be as effective (57954).
• Postmenopausal conditions. It is unclear if oral or intravaginal kudzu is beneficial for postmenopausal conditions. Details: A small clinical study in postmenopausal individuals shows that taking kudzu containing isoflavones 100 mg orally once daily for 3 months improves flexible thinking and attention when compared with control. However, it does not appear to improve total cholesterol, low-density lipoprotein (LDL) cholesterol, or sex hormone levels (11386). Another small clinical study in postmenopausal individuals shows that taking kudzu 20 mg, 30 mg, or 50 mg daily for 24 weeks improves vaginal dryness and pH when compared with baseline, but not when compared with placebo. It also decreases a specific biomarker of bone turnover, called bone alkaline phosphatase, when compared with placebo (57924,57929). It is unclear if this correlates with improved bone density or with a reduced risk of osteoporosis. Kudzu has also been evaluated as an intravaginal gel. One small clinical study shows that applying 0.5 grams of kudzu 6% gel into the vagina every night for 2 weeks, followed by 3 nights each week for 9 weeks, improves vaginal symptoms of dryness, soreness, irritation, and abnormal discharge similarly to conjugated estrogen cream applied on the same schedule. However, kudzu gel is less effective than conjugated estrogen cream for improving overall vaginal health (96740). Another small clinical study of postmenopausal patients shows that applying 0.5 grams of kudzu 6% gel intravaginally every night for 3 weeks increases vaginal arterial blood flow and restores atrophic vaginal tissue when compared with placebo after 12 weeks (110702). In contrast, a similar study shows that applying 0.5 grams of kudzu 5% gel into the vagina every night for 2 weeks, followed by 3 nights each week for 10 weeks, does not improve vaginal symptoms when compared with placebo gel (105521). However, the study may have been inadequately powered to detect a difference between groups.
• Rhinosinusitis. Although there is interest in using oral kudzu for rhinosinusitis, there is insufficient reliable information about the clinical effects of kudzu for this condition.
• Stroke. Although there is interest in using the injectable kudzu constituent puerarin for stroke, there is insufficient reliable information about the clinical effects of oral kudzu for this condition. More evidence is needed to rate kudzu for these uses.

(Read more about KUDZU)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Dysmenorrhea. In patients with dysmenorrhea, preliminary clinical research shows that taking a palm sap-sweetened herbal decoction 180 mL made with a combination of mace 3 grams and Cassia fistula 21 grams for 3 days starting just before expected menstruation and repeating for two menstrual cycles reduces pain by a large amount and the duration of pain by a small amount when compared with the same three days of the menstrual cycle at baseline. In addition, it was as effective as taking mefenamic acid 500 mg twice daily for 3 days starting on the first day of menstruation. When the average 3-day pain was compared, the decoction was slightly more effective than mefenamic acid (103376). It is unclear if these are effects are due to mace, Cassia fistula, or the combination.
• Urinary incontinence. In women with mixed urinary incontinence of at least 2 months duration, preliminary clinical research shows that taking mace powder 1.5 grams twice daily for 3 months, in addition to doing pelvic floor muscle training, has a large benefit on severity of symptoms when compared with those using pelvic floor training alone (103377). More evidence is needed to rate mace for these uses.

(Read more about MACE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. It is unclear if oral moringa seed is beneficial in patients with asthma. Details: A small clinical study in patients with mild to moderate asthma shows that taking powdered dried moringa seed kernels 3 grams twice daily for 3 weeks reduces the severity of asthma symptoms, including dyspnea, wheezing, chest tightness, and cough, and improves lung function when compared to baseline (19278). The validity of this finding is limited by the lack of a control group.
• Child growth. It is unclear if oral moringa, taken during the second or third trimester or while breastfeeding, can improve infant growth. Details: An observational follow-up of a large randomized clinical trial conducted in Indonesia during the second trimester or 1 month after giving birth shows that taking 500 mg moringa leaf powder or extract daily for 4 months does not reduce stunting in infants followed for up to 11 months when compared with an unspecified dose of iron and folate (105471,105472). Other observational data, also from a large randomized clinical trial conducted in Indonesia, suggests the rate of stunted growth in children aged 36 to 42 months is 25% after taking 500 mg moringa leaf extract daily for 3 months during the third trimester, compared to 42% with 500 mg moringa leaf flour, or 33% with iron 60 mg and 0.2 mcg folic acid (110645). Researchers propose that differences in the nutritional content between moringa leaf extract and flour may account for the variation in results among forms.
• Diabetes. It is unclear if oral moringa leaf is beneficial in patients with diabetes; research is conflicting. Details: A small clinical study in therapy-naïve patients with type 2 diabetes shows that taking 4 grams of moringa leaf powder twice daily for 4 weeks does not affect fasting blood glucose (FBG) or postprandial glucose (PPG) when compared with placebo (105470). These findings are limited by the small size and short duration of the study. A non-randomized clinical study in patients with type 2 diabetes who are taking a sulfonylurea shows that taking 2 tablets containing an unspecified amount of powdered moringa leaf in addition to following a calorie-restricted diet for 90 days does not reduce glycated hemoglobin (HbA1c) when compared with standard treatment, although it modestly reduces PPG when compared with baseline (90572). Another small non-randomized clinical study in patients with type 2 diabetes who are taking hypoglycemic agents shows that taking powdered moringa leaf 8 grams daily for 40 days in addition to following a calorie-restricted diet reduces FBG, PPG, and lipid levels when compared with baseline (97208). It is unclear if any benefit identified in these studies is due to moringa or calorie restriction. Additionally, the validity of these findings is limited by the lack of a statistical comparison to the control group.
• HIV/AIDS. It is unclear if oral moringa leaf is beneficial in patients with HIV; research is conflicting. Details: Preliminary clinical research in normal weight Congolese patients with HIV who are on antiretroviral therapy shows that taking dried moringa leaf powder 10 grams three times daily with meals for 6 months increases body mass index (BMI) by 2 kg/m2 when compared with a nutritional counseling only group. However, there was no difference in immune function as measured by CD4 counts (97210). Results of other research are in conflict. A large clinical study in Nigerian adults treated with standard antivirals for HIV shows that taking moringa leaf powder 5 grams three times daily with meals for 6 months modestly increases CD4 counts but does not impact viral load or anthropometric parameters (i.e., weight, BMI) when compared with placebo. However, most patients were normal or overweight, and over half had an undetectable viral load at baseline (110648). Secondary analysis of this data suggests taking moringa may also improve quality of life (110649). However, the validity of this finding is limited by the inability to mask the taste of moringa leaf powder; patients may have been biased by knowing their study group assignment. Similarly, a small open label clinical study also in Nigerian adults treated with antiviral therapy for HIV shows that taking a moringa 200 mg capsule daily (Formula 10 Herbal Products, Nigeria) for 3 months modestly increases CD4 counts, lymphocyte and platelet counts, and hemoglobin when compared with antiviral therapy alone (110650).
• Hyperlipidemia. It is unclear if oral moringa leaf is beneficial in patients with hyperlipidemia. Details: One small clinical study in patients with hyperlipidemia shows that taking atorvastatin 10 mg daily with powder of an unspecified part of the moringa plant 1 gram twice daily for 45 days modestly reduces levels of total cholesterol and triglycerides when compared with taking atorvastatin alone (112639). Another small clinical study in patients with type 2 diabetes shows that taking powdered moringa leaf 8 grams daily in addition to following a calorie restricted diet for 40 days modestly reduces low-density lipoprotein (LDL) cholesterol, total cholesterol, and triglyceride levels when compared with baseline (97208). The validity of these findings is limited by the lack of a statistical comparison to the control group, as well as small study size and short duration. In contrast, one small clinical study in patients of Indian descent with hyperlipidemia shows that taking 8 tablets of standardized dehydrated moringa drumstick leaf (DDL) 4.6 grams daily for 50 days has no effect on lipid levels when compared with baseline (97212).
• Iron deficiency anemia. It is unclear if oral moringa leaf flour is beneficial for anemia during pregnancy. Details: A small clinical study in pregnant patients with anemia in Indonesia shows that consuming biscuits enriched with 5.6 grams of moringa leaf flour, in addition to iron 500 mg, daily for 60 days increases hemoglobin by 1 g/dL, compared to 0.66 mg/dL with iron 500 mg daily alone. (110647). The validity of this study is limited by poor methodology, including lack of randomization and blinding.
• Impaired glucose tolerance (prediabetes). It is unclear if oral moringa leaf powder is beneficial for patients with prediabetes. Details: A small clinical study in treatment-naïve adults with prediabetes shows that taking moringa leaf powder 2400 mg daily for 12 weeks modestly improves fasting blood glucose and glycated hemoglobin (HbA1c) but does not improve markers of insulin resistance or anthropometric measures (i.e. weight, BMI, waist circumference) when compared with placebo (110646).
• Lactation. Small clinical studies suggest that oral moringa leaf may modestly increase breastmilk volume during the first week of lactation. Details: A meta-analysis of 3 small clinical trials in breastfeeding patients shows that when started on postpartum day 3, moringa leaf increases breastmilk volume by about 120 mL per expression by day 7 when compared to control (90573). Studies included in the analysis used specific capsules containing moringa leaf (Natalac, Gruppo Medica Inc.) 250 mg twice daily on postpartum days 3-5 (20578), and specific capsules containing moringa leaf (Pro-Lacta, Pascual Laboratories, Inc.) 350 mg twice daily starting on postpartum day 3 and continuing for one week (90571). However, due to methodological limitations and the short duration of the included trials, the clinical significance of this finding is uncertain.
• Malnutrition. It is unclear if oral moringa leaf is beneficial for children with malnutrition. Details: One small clinical study in children with mild-to-moderate malnutrition shows that supplementing food with powdered dried moringa leaf 15 grams twice daily for 2 months results in 23 of 30 children having a 20% or greater improvement in weight, compared with only 2 of 30 children receiving no additional intervention (90576). It is unclear if maternal consumption of moringa leaves prevents malnutrition in infants. An observational follow-up of a large randomized clinical trial in Indonesian patients in their second trimester or one month postpartum shows that consuming four capsules, each containing 500 mg moringa leaf powder or extract, daily for 4 months might protect the infant against being underweight, but does not reduce stunting in infants followed for up to 11 months, when compared with an unspecified dose of iron and folate (105471,105472).
• Menopausal symptoms. It is unclear if oral moringa leaf improves menopausal symptoms. Details: A small clinical study in healthy postmenopausal patients shows that taking powdered moringa leaves 7 grams with food daily for 3 months modestly improves menopausal symptoms such as hot flashes and sleeping problems when compared with no dietary additives (90575).
• Obesity. Oral moringa leaf has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study shows that taking a combination product containing moringa leaf extract 200 mg, green coffee bean extract 300 mg, banaba leaf extract 100 mg, and vitamin D3 500 IU (CraveCheck, Advocare International) daily for 2 months does not reduce body weight when compared with placebo. In fact, patients in the placebo group showed slightly greater weight loss than patients in the treatment group. However, taking the combination product appears to reduce fat mass and increase fat-free or lean mass as measured by dual energy X-ray absorptiometry, suggesting that the combination product might improve body composition (97211). It is not clear if this effect is due to moringa, the other ingredients, or the combination.
• Oral leukoplakia. It is unclear if topical moringa leaf improves oral leukoplakia. Details: Preliminary clinical research in patients with oral leukoplakia shows that topical application 3 times daily for 3 months with a gel providing moringa leaf extract 2% reduces lesion size by about 77% compared to baseline. Moringa gel is modestly more effective for reducing lesion size than a specific cream (Retino-A) (112640). The validity of these findings is limited by the lack of a placebo group.
• Vitamin A deficiency. It is unclear if oral moringa leaf is beneficial in infants deficient in vitamin A. Details: Preliminary clinical research conducted in rural Ghana shows that vitamin A-deficient infants aged 8-12 months who receive cereal supplemented with moringa leaf powder for 6 weeks do not have a significant improvement in vitamin A status when compared with those given cereal without moringa (98455). More evidence is needed to rate moringa for these uses.

(Read more about MORINGA)

There is insufficient reliable information available about the effectiveness of pellitory.

(Read more about PELLITORY)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Athletic performance. Preliminary clinical research in healthy, untrained adults shows that taking safed musli root powder 1 gram three times daily for 60 days increases distance traveled during a 6-minute walk test and a 6-minute cycling test when compared with placebo (104158).
• Muscle strength. Preliminary clinical research in healthy, untrained adults shows that taking safed musli root powder 1 gram three times daily for 60 days does not increase hand grip strength when compared with placebo (104158). More evidence is needed to rate safed musli for these uses.

(Read more about SAFED MUSLI)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Alzheimer disease. Oral shilajit has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small preliminary clinical trial in adults with probable Alzheimer disease shows that taking shilajit 200 mg, in combination with folate and vitamins B6 and B12, daily for 24 weeks modestly prevents cognitive deterioration based on some measures compared with placebo (112637). This study lacks a complete description of methodology and findings. Also, it is not clear if these effects are due to shilajit, the other ingredients, or the combination.
• Athletic performance. Although there is interest in using oral shilajit for improving athletic performance, there is insufficient reliable information about the clinical effects of shilajit for this purpose.
• Benign prostatic hyperplasia (BPH). Although there is interest in using oral shilajit for BPH, there is insufficient reliable information about the clinical effects of shilajit for this condition.
• Diabetes. Although there is interest in using oral shilajit for diabetes, there is insufficient reliable information about the clinical effects of shilajit for this condition.
• Fractures. It is unclear if oral shilajit is beneficial for fracture repair. Details: Clinical research in adults shows that taking shilajit 500 mg twice daily for 28 days following surgery for a new tibia fracture results in a mean time to bone union of 129 days compared with 153 days in those taking placebo (112616). This study is limited by the large attrition rate, leaving only 62 patients X-rayed for the primary outcome.
• Hyperlipidemia. Although there is interest in using oral shilajit for hyperlipidemia, there is insufficient reliable information about the clinical effects of shilajit for this condition.
• Hypertension. Although there is interest in using oral shilajit for hypertension, there is insufficient reliable information about the clinical effects of shilajit for this condition.
• Male infertility. It is unclear if oral shilajit is beneficial for male infertility. Details: Preliminary clinical research in adults with oligospermia shows that taking shilajit 100 mg twice daily for 90 days increases total sperm count by 61% and motility by at least 12% when compared to baseline. Normal sperm count was increased by 19% and white blood cell counts were reduced by 55% (112621). The validity of this study is limited by the lack of a comparator group.
• Muscle strength. It is unclear if oral shilajit is beneficial for muscle strength. Details: A small clinical trial in recreationally-active adults with baseline maximal strength above the 50^th percentile shows that taking shilajit (PrimaVie, Natreon Inc., New Brunswick, NJ) 500 mg daily for 8 weeks modestly prevents a decline in this muscle strength after a fatiguing protocol when compared with taking shilajit 250 mg daily or placebo. However, there was no effect in the adults below the 50th percentile for maximal strength at baseline (112614). This study is limited by the inclusion of only male participants.
• Osteopenia. It is unclear if oral shilajit is beneficial for osteopenia. Details: A small clinical trial in postmenopausal adults with osteopenia or osteoporosis shows that taking shilajit (PrimaVie, Natreon Inc., New Brunswick, NJ) 250 mg or 500 mg daily, in a dose-responsive manner, for 48 weeks modestly increases bone density at the lumbar spine and femoral neck when compared with placebo (112613). The study is limited by the inclusion only of patients within 5 years of menopause lacking conventional hormonal therapy or anti-resorptive medication. It is unclear if these results are generalizable to other populations, including males or premenopausal or older females.
• Osteoporosis. It is unclear if oral shilajit is beneficial for osteoporosis. Details: A small clinical trial in postmenopausal adults with osteopenia or osteoporosis shows that taking shilajit (PrimaVie, Natreon Inc., New Brunswick, NJ) 250 mg or 500 mg daily, in a dose-responsive manner, for 48 weeks modestly increases bone density at the lumbar spine and femoral neck when compared with placebo (112613). The study is limited by the inclusion only of patients within 5 years of menopause lacking conventional hormonal therapy or anti-resorptive medication. It is unclear if these results are generalizable to other populations, including males or premenopausal or older females.
• Sexual desire. Although there is interest in using oral shilajit for increasing sexual desire, there is insufficient reliable information about the clinical effects of shilajit for this purpose.
• Sexual dysfunction. Although there is interest in using oral shilajit for sexual dysfunction, there is insufficient reliable information about the clinical effects of shilajit for this purpose. More evidence is needed to rate shilajit for these uses.

(Read more about SHILAJIT)

POSSIBLY EFFECTIVE

• Sexual dysfunction. Oral tribulus seems to improve sexual experience in females with hypoactive sexual desire disorder (HSDD) or sexual dysfunction. Some research also shows that oral tribulus improves sexual function in males. Details: Clinical research in premenopausal and postmenopausal patients with HSDD shows that taking tribulus 250 mg three times daily (Androsten, Herbarium) for 3 months improves overall satisfaction and lubrication, as well as pain, desire, sexual arousal, and ability to reach orgasm, when compared with placebo (92027,97331,97332). Other preliminary clinical research in females with HSDD shows that taking tribulus extract 7.5 mg daily for 4 weeks improves sexual desire, arousal, satisfaction, orgasm, pain, and lubrication when compared with placebo (92022). A nonblinded clinical study comparing tribulus dosing regimens shows that taking oral tribulus 280 mg, either once daily or in three divided daily doses, for 90 days results in similar improvements in sexual dysfunction, regardless of menopausal status. However, neither dosing schedule increases clitoral blood flow when compared with baseline (108551). Tribulus has also been studied in males. One clinical study in males with erectile dysfunction, with or without HSDD, shows that taking tribulus (Tribestan, Sopharma AD) 500 mg three times daily for 3 months improves sexual desire and intercourse satisfaction when compared with placebo (97330).

POSSIBLY INEFFECTIVE

• Athletic performance. Oral tribulus does not seem to improve athletic performance. Details: Small clinical studies in athletes show that taking tribulus orally, alone or in combination with other ingredients such as androstenedione, most often as 450-770 mg daily for 5-8 weeks, does not seem to enhance body composition or exercise performance when compared with placebo or a control group (7514,13255,92029,108552).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angina. It is unclear if oral tribulus is beneficial for angina. Details: Preliminary clinical research shows that taking a tribulus extract orally might reduce symptoms of angina when compared with a control (3931).
• Atopic dermatitis (eczema). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Some preliminary clinical research shows that taking tribulus orally in combination with 9 other herbs (Zemaphyte) daily for 8 weeks reduces redness and skin lesions in adults and children with nonexudative atopic dermatitis (12627,12628). However, other research shows no effect (12630). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Bacterial vaginosis. Topical tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with bacterial vaginosis shows that using a specific vaginal suppository (Forzajeh) containing tribulus, myrtle, fennel, and tamarind daily for 1 week is as effective as metronidazole vaginal suppository for improving vaginal discharge volume and odor, pelvic pain, cervical inflammation, and vaginal pH (100339). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Benign prostatic hyperplasia (BPH). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in adults with BPH shows that taking a combination supplement (Prostalyn, East India Pharmaceutical Works Ltd.) containing tribulus 600 mg and curry leaf (Murraya koenigii) 600 mg twice daily for 12 weeks improves prostate symptoms when compared to baseline, with no difference when compared to tamsulosin 400 mcg daily. This supplement also seems to reduce prostate volume by around 2 mL (92033).
• Cancer. Although there is interest in using oral tribulus for cancer, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Chronic fatigue syndrome (CFS). Although there is interest in using oral tribulus for CFS, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Diabetes. It is unclear if oral tribulus is beneficial for diabetes. Details: Preliminary clinical research in females with type 2 diabetes who are taking oral hypoglycemic agents shows that taking tribulus extract powder 500 mg twice daily for 3 months modestly reduces fasting glucose and postprandial glucose levels, but not glycated hemoglobin, when compared with placebo. However, the validity of these findings is limited by the difference in diabetes severity between groups at baseline (97327).
• Erectile dysfunction (ED). It is unclear if oral tribulus is beneficial for ED. Research is conflicting. Details: Clinical research in patients with ED shows that taking tribulus (Tribestan, Sopharma AD) 500 mg three times daily for 3 months does not provide a clinically beneficial improvement in erectile function when compared with placebo (97330). Other clinical research shows that taking tribulus 400 mg twice daily for 30 days does not improve erectile function when compared with placebo (92031). However, one preliminary clinical study in patients with partial androgen deficiency shows that taking tribulus 250 mg three times daily for 3 months improves erectile function when compared to baseline (92028). Tribulus has also been studied in combination with other ingredients. Preliminary clinical research shows that taking a combination supplement (Tradamix TX1000, Tradapharma Sagl) containing tribulus 450 mg, brown algae 300 mg, and chitosan 250 mg twice daily for 3 months improves sexual satisfaction, desire, ejaculation function, and sexual quality of life when compared with placebo in patients with mild-to-moderate ED (92030). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Exercise-induced muscle damage. It is unclear if oral tribulus is beneficial for exercise-induced muscle damage. Details: Clinical research in a small number of healthy, untrained males shows that taking tribulus 500 mg daily for 2 weeks prior to performing resistance exercise reduces markers of muscle damage, including creatine phosphokinase (CPK) and lactate dehydrogenase (LDH), but does not reduce levels of the inflammatory markers interleukin-6 (IL-6) or C-reactive protein (CRP), when compared with placebo (103236). However, another small clinical study in male CrossFit athletes shows that taking tribulus 770 mg capsules (Quamtrax Pharmaceuticals) daily for 42 days does not reduce CPK but does improve CRP and oxidant status when compared with placebo (111747). However, it is unclear whether any improvements are clinically significant. A very small crossover clinical study in trained male athletes shows that taking 20 mg/kg/day of tribulus in 3 divided doses 30 minutes before meals with 500 mL of water for 4 weeks does not reduce muscle soreness after intensive aerobic exercise when compared with placebo (111746).
• Gonorrhea. Although there is interest in using oral tribulus for gonorrhea, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Hypercholesterolemia. Although there is interest in using oral tribulus for hypercholesterolemia, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Hypertension. It is unclear if oral tribulus can lower blood pressure. Details: In patients with pre-hypertension, clinical research shows that taking powdered tribulus fruit 2 grams three times daily for 2 months reduces systolic and diastolic blood pressure by 6 and 5 mmHg, respectively, when compared with placebo (105245). It is unclear what effect Tribulus may have in patients with diagnosed hypertension.
• Kidney stones (nephrolithiasis). Although there is interest in using oral tribulus for kidney stones, there is insufficient reliable information about the clinical effects of tribulus for this purpose.
• Male infertility. It is unclear if oral tribulus is beneficial for male infertility; the available research is conflicting. Details: Case series suggest that taking a specific tribulus product (Tribestan, Sopharma) 250 mg three times daily for 30 days improves ejaculate volume, sperm concentration, and sperm motility in patients with infertility due to oligoasthenozoospermia (78865), and improves libido and erections in patients with primary hypogonadism (78868). Conversely, a small clinical study in patients with oligozoospermia shows that taking tribulus granules 6 grams daily for 60 days does not improve sperm count when compared with placebo (92032). In patients with idiopathic infertility, taking tribulus 250 mg three times daily for 3 months does not increase sperm concentration, sperm motility, serum testosterone levels, or luteinizing hormone levels (97328). The difference in these findings might be due to the small study sizes, as well as the variable etiology of infertility.
• Menopausal symptoms. Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research shows that taking a combination product containing tribulus 40 mg, ginger, saffron, and Ceylon cinnamon (Aphrodit, Goldaru Company) twice daily for 4 weeks improves mental and physical symptoms during menopause, but not genitourinary symptoms, when compared with placebo (97326). It is not clear if this effect is due to tribulus, the other ingredients, or the combination.
• Osteoporosis. Although there is interest in using oral tribulus for osteoporosis, there is insufficient reliable information about the clinical effects of tribulus for this condition.
• Polycystic ovary syndrome (PCOS). Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One clinical study shows that taking tribulus extract (Tribulus forte, Mediherb, Integra Healthcare Ltd) 245 mg daily along with other ingredients and lifestyle modification during the follicular phase of the menstrual cycle for 3 months improves some symptoms of PCOS, including a 33% reduction in oligomenorrhea or amenorrhea and a 43-day reduction in the duration between menstrual cycles, when compared with lifestyle modification alone. Taking tribulus with other ingredients also improves quality of life by about 30% and reduces body mass index by 1 kg/m2 when compared with placebo. Although the conception rate increased 4-fold in patients taking the combination product, the live birth rate was similar to those taking placebo. (97216). It is unclear if these effects are due to tribulus, the other ingredients, or the combination.
• Premature ejaculation. Oral tribulus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that taking a combination product containing tribulus, 5-HTP, winter savory, and chanca piedra (EiacuMev, Farmaceutica Mev) daily for 3 months improves time to ejaculation by 30 seconds and reduces symptoms related to premature ejaculation when compared to control (97016). More evidence is needed to rate tribulus for these uses.

(Read more about TRIBULUS)

POSSIBLY SAFE ...when used orally and appropriately, short-term. Ashwagandha has been used with apparent safety in doses of up to 1250 mg daily for up to 6 months (3710,11301,19271,90649,90652,90653,97292,101816,102682,102683) (102684,102685,102687,103476,105824,109586,109588,109589,109590). ...when used topically. Ashwagandha lotion has been used with apparent safety in concentrations up to 8% for up to 2 months (111538).

PREGNANCY: LIKELY UNSAFE
when used orally. Ashwagandha has abortifacient effects (12).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about ASHWAGANDHA)

POSSIBLY SAFE ...when used orally and appropriately. Powdered formulations of cowhage seed that are standardized to provide levodopa 75-400 mg daily have been used with apparent safety for up to 20 weeks (7020,7203,97266).

POSSIBLY UNSAFE ...when the hair of the cowhage bean pod is used orally or topically. The bean pod hairs are strong irritants and can cause severe itching, burning, and inflammation (18).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about COWHAGE)

LIKELY SAFE ...when consumed in amounts commonly found in foods (6,2076).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Indian gooseberry fruit extract has been used safely in doses of up to 1000 mg daily for up to 6 months, 1500 mg daily for up to 8 weeks, or 2000 mg daily for up to 4 weeks (92515,99238,99240,99241,102855,102857,105352,105354,105356). Indian gooseberry leaf extract has been used with apparent safety at a dose of 750 mg daily for 10 days (99846). ...when used topically and appropriately. An emulsion containing Indian gooseberry extract 3% and other ingredients has been applied safely to the skin twice daily for up to 60 days (111571).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about INDIAN GOOSEBERRY)

POSSIBLY SAFE ...when used orally and appropriately. Kudzu appears to be safe for up to 4 months (10386,11386,92257). ...when used intravaginally and appropriately. Kudzu 5% to 6% gel has been used with apparent safety for up to 12 weeks (96740,105521,110702).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about KUDZU)

LIKELY SAFE ...when used orally and appropriately in amounts commonly found in foods. Mace is commonly used as a spice. Mace and mace oil have Generally Recognized as Safe (GRAS) status in the US (4912).

POSSIBLY SAFE ...when used orally and appropriately in medicinal amounts. Mace powder in doses of up to 1.5 grams twice daily has been used with apparent safety for up to 3 months (103377). There is insufficient reliable information available about the safety of larger doses of mace. However, severe cardiovascular, gastrointestinal, neurologic, ocular, and psychiatric adverse events have been reported following high intake of the related herb nutmeg (19293,19492,25538). Theoretically, high doses of mace may have similar effects, although there have been no reported cases in humans. There is insufficient reliable information available about the safety of mace when used topically.

PREGNANCY: POSSIBLY UNSAFE
when used orally in medicinal amounts. Mace might have abortifacient activity, and its safrole content might be mutagenic (12).

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about MACE)

LIKELY SAFE ...when used orally in food amounts. The leaves, fruit, and seeds are commonly used in foods (16341,16344,90573).

POSSIBLY SAFE ...when moringa leaf or seed is used orally and appropriately in medicinal amounts, short-term. Tablets and capsules containing up to 30 grams of moringa leaf powder have been used daily with apparent safety in clinical studies lasting up to 6 months (20578,90572,90572,97209,97210). A dried moringa seed kernel powder has also been used with apparent safety in doses of 3 grams twice daily for 3 weeks (19278). ...when moringa leaf extract is used topically and appropriately. Moringa leaf extract 2% has been used 3 times daily with apparent safety in a clinical trial lasting 3 months (112640).

POSSIBLY UNSAFE ...when moringa root or root bark are used orally. Moringa root contains spirochin, a potentially toxic alkaloid, while moringa root bark contains stimulant alkaloids similar to ephedrine. Although spirochin has not been studied in humans, animal data shows that it can cause nerve paralysis (63764).

CHILDREN: POSSIBLY SAFE
when moringa leaf is used orally and appropriately, short-term. Powdered dried moringa leaf has been used with apparent safety in doses of 15 grams twice daily for up to 2 months (90576).

PREGNANCY: POSSIBLY SAFE
when the leaf is used orally during the second or third trimesters, short-term. Moringa leaf powder or extract 500 mg daily for up to 4 months has been used with apparent safety during the second and third trimesters (105469,105471,105472,110645). There is insufficient reliable information available about the safety of using moringa leaf by mouth during the first trimester.

PREGNANCY: POSSIBLY UNSAFE
when the root, bark, or flower are used orally. Traditionally, moringa root bark and gum from moringa trunk bark have been used to induce abortion. When taken orally along with black peppercorns to induce abortion, moringa root bark may cause fatality (63764). Animal research shows that moringa flower can cause uterine contractions (94634); however, this has not been assessed in humans. There is insufficient reliable information about the safety of using moringa seed during pregnancy; avoid using.

LACTATION: POSSIBLY SAFE
when moringa leaf is used orally, short-term. Moringa leaf powder or extract 2 grams daily has been used during lactation with apparent safety for up to 4 months (20578,90571,90573,105471,105472). There is insufficient reliable information available about the safety of using other parts of moringa during lactation; avoid using.

(Read more about MORINGA)

There is insufficient reliable information available about the safety of pellitory.

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about PELLITORY)

POSSIBLY SAFE ...when used orally and appropriately, short-term. Safed musli root powder has been safely used at a dose of 3 grams daily for up to 60 days (104158).

PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.

(Read more about SAFED MUSLI)

POSSIBLY SAFE ...when processed shilajit is used orally and appropriately. Processed shilajit has been used with apparent safety in doses of 2 grams daily for 45 days or up to 500 mg daily for up to 48 weeks (112613,112614,112615,112616,112617,112618,112619,112621). There is insufficient reliable information available about the safety of crude or unprocessed shilajit when used orally or shilajit when used topically.

PREGNANCY AND LACTATION:
There is insufficient reliable information available about the safety of shilajit when used during pregnancy and lactation.

(Read more about SHILAJIT)

LIKELY UNSAFE ...when the spine-covered fruit is used orally. There have been reports of bilateral pneumothorax and bronchial polyp after oral consumption of the spine-covered fruit (818).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Animal research suggests that tribulus might adversely affect fetal development (12674); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about TRIBULUS)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, taking ashwagandha with antidiabetes drugs might increase the risk of hypoglycemia.  Details There is preliminary clinical evidence suggesting that ashwagandha might lower blood glucose levels. Theoretically, ashwagandha might have additive effects when used with antidiabetes drugs and increase the risk of hypoglycemia (19274,90649,102685).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking ashwagandha with antihypertensive drugs might increase the risk of hypotension.  Details Animal research suggests that ashwagandha might lower systolic and diastolic blood pressure (19279). Theoretically, ashwagandha might have additive effects when used with antihypertensive drugs and increase the risk of hypotension.

BENZODIAZEPINES Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking ashwagandha might increase the sedative effects of benzodiazepines.  Details There is preliminary evidence that ashwagandha might have an additive effect with diazepam (Valium) and clonazepam (Klonopin) (3710). This may also occur with other benzodiazepines.

CNS DEPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking ashwagandha might increase the sedative effects of CNS depressants.  Details Ashwagandha seems to have sedative effects. Theoretically, this may potentiate the effects of barbiturates, other sedatives, and anxiolytics (3710).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, ashwagandha might decrease the levels and clinical effects of CYP1A2 substrates.  Details In vitro research shows that ashwagandha extract induces CYP1A2 enzymes (111404).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, ashwagandha might decrease the levels and clinical effects of CYP3A4 substrates.  Details In vitro research shows that ashwagandha extract induces CYP3A4 enzymes (111404).

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking ashwagandha with hepatotoxic drugs might increase the risk of liver damage.  Details Ashwagandha has been linked to cases of acute hepatitis, liver failure, hepatic encephalopathy, autoimmune hepatitis, the need for liver transplantation, and death due to liver failure (102686,107372,110490,110491,111533,111535,112111,113610).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking ashwagandha might decrease the effects of immunosuppressants.  Details Ashwagandha has demonstrated immunostimulant effects in humans (3710,3711,4114,11301,106786). Animal research has shown that ashwagandha can attenuate the immunosuppression caused by cyclophosphamide (3711,4114).

THYROID HORMONE Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = B Ashwagandha might increase the effects and adverse effects of thyroid hormone.  Details Concomitant use of ashwagandha with thyroid hormones may cause additive therapeutic and adverse effects. Preliminary clinical research and animal studies suggest that ashwagandha boosts thyroid hormone synthesis and secretion (19281,19282,97292). In one clinical study, ashwagandha increased triiodothyronine (T3) and thyroxine (T4) levels by 41.5% and 19.6%, respectively, and reduced serum TSH levels by 17.4% from baseline in adults with subclinical hypothyroidism (97292).

(Read more about ASHWAGANDHA)

ANESTHESIA Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of cowhage and anesthesia might increase the risk of arrhythmias.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of levodopa with cyclopropane or halogenated hydrocarbon anesthesia has led to arrhythmias. Other anesthetics have not been implicated (15). Use other anesthetics in patients taking cowhage or tell patients to stop taking cowhage at least 2 weeks before surgery.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of cowhage and antidiabetes drugs might increase the risk of hypoglycemia.  Details Animal research shows that cowhage might have hypoglycemic effects (7221).

ANTIPSYCHOTIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of cowhage might decrease the clinical effects of antipsychotic drugs.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of levodopa might counteract the antidopaminergic effects of antipsychotic medications (15).

GUANETHIDINE (Ismelin) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, concomitant use of cowhage and guanethidine might increase the risk of hypotension.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of levodopa with guanethidine might cause additive hypotension (15); avoid using.

LEVODOPA Interaction Rating = Major Do not take this combination. Severity = Moderate •  Occurrence = Likely •  Level of Evidence = D Concomitant use can increase the risk of levodopa-related adverse effects.  Details Cowhage contains levodopa. Some cowhage products have been standardized to contain 75-400 mg of levodopa per dose (7020,7205,46334,46336,94723,94724).

METHYLDOPA (Aldomet) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, concomitant use of cowhage and methyldopa might increase the risk of hypotension.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of levodopa with methyldopa might cause additive hypotension. In addition, methyldopa may inhibit peripheral decarboxylation of levodopa and increase levodopa levels in the central nervous system (15); avoid using.

MONOAMINE OXIDASE INHIBITORS (MAOIs) Interaction Rating = Major Do not take this combination. Severity = High •  Occurrence = Probable •  Level of Evidence = D Theoretically, concomitant use of cowhage and non-selective MAOIs might increase the risk of hypertensive crisis.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of levodopa with non-selective MAOIs might cause hypertensive crisis. However, this interaction has not been reported with MAO-B selective inhibitors such as selegiline (15).

TRICYCLIC ANTIDEPRESSANTS (TCAs) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of TCAs might reduce the levels and clinical effects of cowhage.  Details Cowhage contains levodopa (7020,7205,46334,46336,94723,94724). Use of TCAs might reduce the absorption of levodopa. Some case reports describe patients that developed hypertension and dyskinesia when taking both levodopa and TCAs (15).

(Read more about COWHAGE)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking Indian gooseberry 500 mg along with clopidogrel 75 mg or ecosprin 75 mg, as a single dose or for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with clopidogrel 75 mg or ecosprin 75 mg alone (92514). Until more is known, use caution when taking Indian gooseberry in combination with anticoagulant/antiplatelet drugs.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Taking Indian gooseberry with antidiabetes drugs might increase the risk of hypoglycemia.  Details Clinical research shows that taking Indian gooseberry fruit or fruit extract alone or in conjunction with antidiabetes medications can lower blood glucose levels (31025,105355,105356,111569). Dose adjustments to diabetes medications might be necessary.

ASPIRIN Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with aspirin; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking a single dose of Indian gooseberry 500 mg along with ecosprin 75 mg, or taking a combination of Indian gooseberry 500 mg twice daily plus ecosprin 75 mg once daily for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with ecosprin 75 mg alone (92514).

CLOPIDOGREL (Plavix) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian gooseberry may increase the risk of bleeding if used with clopidogrel; however, research is conflicting.  Details Clinical research shows that taking Indian gooseberry 500 mg as a single dose or twice daily for 10 days reduces platelet aggregation by about 24% to 36%, increases bleeding time by about 3.8-5.9 seconds, and increases clotting time by about 9.8-12.7 seconds when compared to baseline. However, taking a single dose of Indian gooseberry 500 mg along with clopidogrel 75 mg, or taking a combination of Indian gooseberry 500 mg twice daily plus clopidogrel 75 mg once daily for 10 days, does not significantly reduce platelet aggregation or increase bleeding time or clotting time when compared with clopidogrel 75 mg alone (92514).

(Read more about INDIAN GOOSEBERRY)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, kudzu may increase the risk of bleeding if used with antiplatelet or anticoagulant drugs.  Details Kudzu isoflavones are reported to have antiplatelet activity (13278,13291).

ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, taking kudzu with antidiabetes drugs might increase the risk of hypoglycemia.  Details Kudzu might lower blood glucose levels and have additive effects in patients treated with antidiabetic agents (13285,13292,57868,57951). The dose of diabetes medications might need to be adjusted.

CAFFEINE Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = D Theoretically, taking kudzu with caffeine might increase levels of caffeine.  Details In healthy males injected with the kudzu constituent puerarin, caffeine clearance and metabolism is inhibited (23583). This effect has been attributed to inhibition of cytochrome P450 1A2 (CYP1A2) enzyme, which is involved in caffeine metabolism. It is unclear if taking kudzu orally would have this same effect.

ESTROGENS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = B Theoretically, kudzu might alter the effects of estrogen therapy.  Details Some research suggests that kudzu has estrogenic effects (11386,57874,57877). This may enhance or inhibit the effects of estrogen therapy.

HEPATOTOXIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use might have additive hepatotoxic effects.  Details There is some concern that kudzu can adversely affect the liver (88777,92259,92260,92262).

METHOTREXATE (Trexall, others) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking kudzu with methotrexate might increase the risk of methotrexate toxicity.  Details Preclinical research suggests that kudzu extract greatly reduces the elimination and increases the toxicity of methotrexate. Kudzu might inhibit organic anion transporters (OATs) that are responsible for hepatobiliary and renal excretion of anions, similar to the interaction between methotrexate and non-steroidal anti-inflammatory drugs (NSAIDs) (13296).

TAMOXIFEN (Nolvadex) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, kudzu might interfere with tamoxifen activity.  Details Some research suggests that kudzu may have estrogenic effects (11386,110702).

(Read more about KUDZU)

(Read more about MACE)

ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, moringa might have additive effects when used with antidiabetes drugs; however, research is conflicting.  Details Animal research shows that moringa can lower blood glucose levels (12249,20571,20573,20574). However, research in humans has not shown consistent blood glucose lowering effects (97207,105470).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, moringa might decrease the levels and clinical effects of CYP1A2 substrates.  Details In vitro research shows that moringa extract induces CYP1A2 enzymes (111404).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, moringa might increase or decrease levels of CYP3A4 substrates.  Details Some in vitro research suggests that moringa inhibits cytochrome P450 3A4 (CYP3A4) (20576). However, other in vitro research suggests that moringa extract induces CYP3A4 enzymes (111404). A pharmacokinetic study in patients with HIV shows no change in the pharmacokinetics of nevirapine, which is partially metabolized by CYP3A4, when administered concomitantly with moringa leaf powder 1.85 grams daily for 14 days (97209).

LEVOTHYROXINE (Synthroid, others) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, moringa leaf can antagonize the effects of levothyroxine.  Details Animal research suggests that moringa aqueous leaf extract might reduce serum triiodothyronine (T3) concentrations by inhibiting the peripheral conversion of thyroxine (T4) to T3 (16348).

NEVIRAPINE (Viramune) Interaction Rating = Minor Be watchful with this combination. Severity = Insignificant •  Occurrence = Unlikely •  Level of Evidence = B Moringa leaf is unlikely to have a clinically significant interaction with nevirapine.  Details Nevirapine is partially metabolized by cytochrome P450 3A4 (CYP3A4). In vitro evidence suggests that moringa inhibits CYP3A4 (20576). However, a pharmacokinetic study in patients with HIV shows no change in nevirapine pharmacokinetics when administered concomitantly with moringa leaf powder 1.85 grams daily for 14 days (97209).

P-GLYCOPROTEIN SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, moringa leaf extract might increase the levels and clinical effects of P-glycoprotein substrates.  Details In vitro research shows that moringa leaf extract inhibits renal P-glycoprotein transport activity (107850). So far, this reaction has not been reported in humans.

(Read more about MORINGA)

(Read more about PELLITORY)

(Read more about SAFED MUSLI)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Taking shilajit with antidiabetes drugs might increase the risk of hypoglycemia.  Details Most human and animal research shows that shilajit can decrease fasting plasma glucose levels (112621,112626,112627,112630,112638). In an animal model, shilajit 100 mg per kg daily enhanced the glucose-lowering ability of both glibenclamide and metformin when given in combination over a 4 week period (112638). Monitor blood glucose levels closely. Dose adjustments might be necessary.

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ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Taking tribulus with antidiabetes drugs might increase the risk of hypoglycemia.  Details Clinical research shows that Tribulus can lower blood glucose levels in adults with type 2 diabetes who are taking antidiabetes medications (97327).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, taking tribulus with antihypertensive drugs might increase the risk of hypotension.  Details Animal research shows that tribulus can lower blood pressure by inhibiting angiotensin-converting enzyme (ACE) (12673). Tribulus has also demonstrated hypotensive effects in pre-hypertensive adults (105245).

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, tribulus might increase the levels and clinical effects of lithium.  Details Tribulus is thought to have diuretic properties (12681). Due to these potential diuretic effects, tribulus might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.

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General ...Orally, ashwagandha seems to be well-tolerated. Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Diarrhea, gastrointestinal upset, nausea, and vomiting. However, these adverse effects do not commonly occur with typical doses.
Serious Adverse Effects (Rare):
Orally: Some case reports raise concerns about acute hepatitis, acute liver failure, hepatic encephalopathy, the need for liver transplantation, and death due to liver failure with ashwagandha treatment.

Dermatologic ...Orally, dermatitis has been reported in three of 42 patients in a clinical trial (19276).

Endocrine ...A case report describes a 73-year-old female who had taken an ashwagandha root extract (unspecified dose) for 2 years to treat hypothyroidism which had been previously managed with levothyroxine. The patient was diagnosed with hyperthyroidism after presenting with supraventricular tachycardia, chest pain, tremor, dizziness, fatigue, irritability, hair thinning, and low thyroid stimulating hormone (TSH) levels. Hyperthyroidism resolved after discontinuing ashwagandha (108745). Additionally, an otherwise healthy adult who was taking ashwagandha extract orally for 2 months experienced clinical and laboratory-confirmed thyrotoxicosis. Thyrotoxicosis resolved 50 days after discontinuing ashwagandha, without other treatment (114111).

Gastrointestinal ...Orally, large doses may cause gastrointestinal upset, diarrhea, and vomiting secondary to irritation of the mucous and serous membranes (3710). When taken orally, nausea and abdominal pain (19276,110490,113609) and gastritis and flatulence (90651) have been reported.

Genitourinary ...In one case report, a 28-year-old male with a decrease in libido who was taking ashwagandha 5 grams daily over 10 days subsequently experienced burning, itching, and skin and mucous membrane discoloration of the penis, as well as an oval, dusky, eroded plaque (3 cm) with erythema on the glans penis and prepuce (32537).

Hepatic ...Orally, ashwagandha in doses of 154 mg to 20 grams daily has played a role in several case reports of cholestatic, hepatocellular, and mixed liver injuries. In most of these cases, other causes of liver injury were excluded, and liver failure did not occur. Symptoms included jaundice, pruritus, malaise, fatigue, lethargy, weight loss, nausea, diarrhea, abdominal pain and distension, stool discoloration, and dark urine. Symptom onset was typically 5-180 days from first intake, although in some cases onset occurred after more than 12 months of use (102686,107372,110490,110491,111533,111535,112111,113610,114113). Laboratory findings include elevated aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase, serum bilirubin, and international normalized ratio (INR) (112111,113610,114113). In most cases, liver enzymes normalized within 1-5 months after discontinuation of ashwagandha (102686,107372,110491,111535,112111,114113). However, treatment with corticosteroids, lactulose, ornithine, ursodeoxycholic acid, and plasmapheresis, among other interventions, was required in one case (111533). Rarely, use of oral ashwagandha has been reported to cause hepatic encephalopathy, liver failure requiring liver transplantation, and acute-on-chronic liver failure resulting in death (110490,113610).

Neurologic/CNS ...Orally, ashwagandha has been reported to cause drowsiness (110492,113609). Headache, neck pain, and blurry vision have been reported in a 47-year-old female taking ashwagandha, cannabis, and venlafaxine. Imaging over the course of multiple years and hospital admissions indicated numerous instances of intracranial hemorrhage and multifocal stenosis of intracranial arteries, likely secondary to reversible cerebral vasoconstriction syndrome (RCVS) (112113). It is unclear whether the RCVS and subsequent intracranial hemorrhages were precipitated by ashwagandha, cannabis, or venlafaxine.

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General ...Orally, adverse effects to cowhage seem to be rare; however, a thorough safety evaluation has not been conducted. Topically, cowhage bean pod or seed may be unsafe.
Most Common Adverse Effects:
Orally: Diarrhea, flatulence, mucosal irritation.
Topically: Erythema, pruritus, rash.

Cardiovascular ...Orally, cowhage has been reported to cause palpitations (7021,7203)

Dermatologic ...Orally, ingestion of hairs from the bean pod or seed can result in significant mucosal irritation and should be avoided.
Topically, hairs on cowhage bean pod or seed can cause severe pruritus (6898). Symptoms include severe itching, burning, inflammation, and erythematous macular rashes (18,6898). Symptoms resolve spontaneously within several hours, but may also be relieved with antihistamines (6898). The hairs can be removed from the skin by washing, but the hairs can also be retained, and transferred to other people, in fabrics and carpets. Clothing and other materials that come in contact with cowhage hairs should also be thoroughly washed (6898).

Gastrointestinal ...Orally, cowhage has been reported to cause flatulence, diarrhea, and dry mouth (7021,7203). Orally, a specific powdered cowhage seed extract (Zandopa, formerly HP-200; Zandu Pharmaceuticals) has been reported to cause nausea, abdominal distention, and vomiting in clinical research when taken in amounts of 22.5-67.5 grams divided into 2-5 doses per day (7020).

Musculoskeletal ...Orally, dyskinesia has been reported in clinical research in about 3% of patients taking a specific powdered cowhage seed extract (Zandopa, formerly HP-200; Zandu Pharmaceuticals) 22. 5-67.5 grams divided into 2-5 doses daily (7020).

Neurologic/CNS ...Orally, cowhage has been reported to cause headaches (7021,7203). Orally, insomnia has been reported in clinical research in about 3% of patients taking a specific powdered cowhage seed extract (Zandopa, formerly HP-200; Zandu Pharmaceuticals) 22.5 grams to 67.5 grams divided into 2-5 doses daily (7020).

Psychiatric ...In a case report, cowhage caused an outbreak of acute toxic psychosis. Symptoms of psychosis included confusion, giddiness, agitation, hallucinations, and paranoid delusions. The cowhage-induced psychosis was successfully treated with intravenous chlorpromazine (7021).

Other ...Orally, cowhage has been reported to cause sweating and changes in urine color, (7021,7203). Theoretically, due to the levodopa constituent, cowhage is likely to cause the same adverse effects that have been attributed to purified, prescription levodopa. Some of these side effects include elevated liver enzymes, respiratory disturbances, urinary retention, muscle cramps, and priapism (15). However, these effects have not yet been reported for cowhage.

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General ...Orally, Indian gooseberry seems to be well tolerated.

Dermatologic ...Orally, itching has been reported by one individual in a clinical trial (105354).

Gastrointestinal ...Orally, epigastric discomfort or dyspepsia have been reported by up to four individuals in clinical trials (105354,105356).

Hepatic ...In clinical research, increased serum glutamic pyruvic transaminase (SGPT) levels, with otherwise normal liver function, occurred in patients taking Ayurvedic formulations containing ginger, Tinospora cordifolia, and Indian gooseberry, with or without Boswellia serrata. The SGPT levels normalized after discontinuing the treatments (89557). It is unclear if these hepatic effects were due to Indian gooseberry or other ingredients contained in the formulations.

Musculoskeletal ...Orally, musculoskeletal pain has been reported by three individuals in a clinical trial (105354).

Neurologic/CNS ...Orally, fatigue has been reported by one individual in a clinical trial (105354).

Pulmonary/Respiratory ...Orally, breathlessness has been reported by one individual in a clinical trial (105354).

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General ...Orally and intravaginally, kudzu seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Elevated liver transaminases.

Cardiovascular ...Orally, side effects of kudzu reported in clinical trials have included palpitations and chest discomfort; however, these effects did not occur more frequently than with placebo (57924,57927).

Dermatologic ...Orally, a side effect of kudzu reported in one clinical trial has included urticaria; however, this effect did not occur more frequently than with placebo (57924). There is one case report of allergic reaction following use of a combination herbal product (Kakkonto) containing kudzu involving a maculopapular eruption starting on the thighs and spreading over the entire body (13111,57886).

Gastrointestinal ...Orally, some side effects of kudzu reported in clinical trials have included nausea, dyspepsia, and bloating; however, these effects did not occur more frequently than with placebo (57927,57942).

Genitourinary ...Intravaginally, irritation of the vulva has been reported with kudzu gel. These cases were generally mild and transient (110702).

Hematologic ...Intravenously, the kudzu derivative, puerarin, has caused intravascular hemolysis (13298,15025,57947).

Hepatic ...Orally, there are several cases reports of liver injury following use of kudzu involving elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels (88777,92260).

Neurologic/CNS ...Orally, a side effect of kudzu reported in one clinical trial has included dizziness; however, this effect did not occur more frequently than with placebo (57924).

Other ...Orally, a side effect of kudzu reported in one clinical trial has included mastodynia; however, this effect did not occur more frequently than with placebo (57942).

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General ...Orally, mace seems to be well tolerated when consumed in appropriate amounts. No adverse effects have been reported, although a thorough evaluation of safety outcomes has not been conducted. However, severe cardiovascular, gastrointestinal, neurologic, ocular, and psychiatric adverse events have been reported following high intake of the related herb nutmeg (19293,19492). Theoretically, high doses of mace may have similar effects, although there have been no reported cases in humans.
Topically, contact and systemic contact-type dermatitis to mace has occurred in rare cases (39898).

Cardiovascular ...There are no reports of adverse cardiovascular events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a related herb, has been associated with non-specific electrocardiographic changes, tachycardia, palpitations, weak pulse, hypotension, chest pain, and flushing (12,19293,19300,25547,25943). Theoretically, high intake of mace may have similar effects.

Dermatologic ...Topically, contact and systemic contact-type dermatitis to mace has occurred in rare cases (39898).

Gastrointestinal ...There are no reports of adverse gastrointestinal events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a similar spice, has been reported to cause nausea and vomiting, epigastric pain, and gastroenteritis (2563,19294,19300). Theoretically, high intake of mace may have similar effects.

Immunologic ...In a case report, inhalation of mace induced an immediate asthmatic reaction (46245).

Musculoskeletal ...There are no reports of adverse musculoskeletal events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a similar herb, has been reported to cause involuntary eye movement (nystagmus), muscle weakness, numbness, and ataxia (2563). Theoretically, high intake of mace may have similar effects.

Neurologic/CNS ...There are no reports of adverse neurologic or central nervous system (CNS)-related events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a similar herb, has been reported to cause headache, dizziness, drowsiness, hot and cold sensations, sensations of limb loss, convulsions, and coma (2563,19294,19300,19487). Theoretically, high intake of mace may have similar effects.

Ocular/Otic ...There are no reports of adverse ocular events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a similar herb, has been reported to cause blurred vision, double and triple vision, and pupil dilation or constriction (2563,25948). Theoretically, high intake of mace may have similar effects.

Psychiatric ...There are no reports of adverse psychiatric events due to ingestion of mace. However, mace contains myristicin, which is structurally similar to certain hallucinogenic chemicals. High intake of nutmeg, a similar herb, has been reported to cause mild to intense visual hallucinations, auditory hallucinations, feelings of impending doom, euphoria, anxiety, disorientation, stupor, agitation, insomnia, and restlessness (12,2563,19300,19489,19492). Theoretically, high intake of mace may have similar effects.

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General ...Orally and topically, moringa leaf and seed seem to be well tolerated. Orally, moringa root and root bark might be unsafe. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Transient diarrhea.
Serious Adverse Effects (Rare):
Orally: Allergic reactions, including anaphylaxis, have been reported.

Cardiovascular ...Orally, a case of bilateral pulmonary embolism after a 5-month history of taking moringa leaf extract is reported in a 63-year-old female without other risks for venous thromboembolism. The patient recovered with standard anticoagulant treatment. Researchers speculate that possible procoagulant effects of moringa may have played a role in this event (110644).

Dermatologic ...Orally, Stevens-Johnson syndrome has been linked to the consumption of moringa leaves. A 53-year-old male presented with fever and generalized maculopapular rash 14 hours after eating food containing moringa leaves. Painful oral ulcers developed by the next day. The patient also reported a similar episode of oral ulcers after eating food containing moringa leaves three months earlier. The patient was treated with oral prednisolone and omeprazole and recovered within two weeks. Researchers speculate that the immunomodulatory effects of moringa may have played a role in this reaction (99876). There are also cases of fixed food eruption to moringa. In one case, suspected fixed food eruption occurred on the trunk and face of a 60-year-old female, reoccurring 8 hours after self reintroduction (112641).

Gastrointestinal ...Orally, moringa leaf powder can cause diarrhea. In a clinical trial, taking moringa leaf powder 8 grams daily resulted in transient diarrhea in 4 of 16 patients (25%) (105470).

Immunologic ...Orally, cases of anaphylaxis are reported after ingestion of young moringa leaves and seedpods. In these cases, positive skin-prick testing confirmed moringa as the causative allergen. The patients recovered after standard treatment (110597,110643). There are also cases of fixed food eruption to moringa. In one case, suspected fixed food eruption occurred on the trunk and face of a 60-year-old female, reoccurring 8 hours after self reintroduction (112641).

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General ...Topically, pellitory may cause dermatological adverse effects (18).

Dermatologic ...Topically, pellitory may cause redness, irritation, and a burning sensation on the skin, due to stimulation of local nerve endings. Signs of skin irritation may occur with overuse (18).

(Read more about PELLITORY)

General ...Orally, safed musli seems to be well tolerated. No adverse effects were reported with safed musli in one clinical study (104158). However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about SAFED MUSLI)

General ...Orally, processed shilajit seems to be well tolerated. Topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.
Serious Adverse Effects (Rare):
Orally: A case report has raised concerns about pseudohyperaldosteronism.

Cardiovascular ...Orally, a case of hypertension related to mineralocorticoid-excess syndrome or pseudohyperaldosteronism is reported in a 37-year-old female following the use of shilajit for 6 months during pregnancy. Electrocardiographic findings were normal. Product discontinuation and treatment with intravenous and oral potassium led to restoration of blood pressure and potassium levels (112622). The role of shilajit in this adverse effect cannot be confirmed. The presence of other ingredients or contaminants in the product was not ruled out.

Endocrine ...Orally, a case of apparent mineralocorticoid excess, or pseudohyperaldosteronism, with edema, increased urinary potassium, calcium, and magnesium loss, hypokalemia, and metabolic alkalosis, is reported in a 37-year-old female following the use of shilajit for 6 months during pregnancy. Product discontinuation and treatment with intravenous and oral potassium led to restoration of potassium levels (112622). The role of shilajit in this adverse effect cannot be confirmed. The presence of other ingredients or contaminants in the product was not ruled out.

Immunologic ...Orally, a case of allergy to shilajit made worse by exercise is reported in a 43-year-old female. Although symptoms were lacking when shilajit 400 mg was taken daily with meals for 3 months, she developed hives within an hour of taking a single dose of shilajit 800 mg. With intramuscular corticosteroids, symptoms improved but did not resolve. The next day, following a meal and physical activity she developed anaphylaxis requiring adrenaline and intravenous corticosteroids (112620).

Neurologic/CNS ...Orally, headache is reported rarely following shilajit intake in clinical research (112616).

(Read more about SHILAJIT)

General ...Orally, tribulus seems to be well tolerated.
Serious Adverse Effects (Rare):
Orally: Cases of liver and kidney injury, seizures, and chronic painful erection with impaired sexual function have been reported. Pneumothorax and bronchial polyp after consuming the spine-covered tribulus fruit have been reported.

Gastrointestinal ...Orally, tribulus can cause abdominal pain, cramping, nausea, vomiting, diarrhea, and constipation (92022,92027). However, in one study, the rates of these gastrointestinal complaints were similar for patients taking tribulus and those receiving placebo (92022).

Genitourinary ...In one case report, a patient taking two tribulus tablets (unknown dose) daily for 15 days presented to the local emergency department with a painful erection lasting 72 hours. The priapism was resolved with medical management; however, post-episode sexual function was impaired (92023).

Hepatic ...In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of tribulus water (92069).

Neurologic/CNS ...Orally, tribulus has been reported to cause general excitation and insomnia. These symptoms were reversed upon discontinuation of the drug or decreasing the dose (78867). In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of tribulus water (92069).

Pulmonary/Respiratory ...In one case report, a patient developed a bilateral pneumothorax after consuming the spine-covered fruit of tribulus (818). In another case report, a patient developed a polyp in the lobar bronchus of the right interior lobe due to the presence of a tribulus fruit spine (78852).

Renal ...In one case report, a patient drinking tribulus water 2 liters daily for two days presented with lower limb weakness, seizures, hepatitis, and acute kidney injury. The patient's condition improved after hemodialysis and discontinuation of the tribulus water (92069). In another case report, a healthy male taking one tribulus tablet (unknown dose) daily for a few months for bodybuilding purposes developed hyperbilirubinemia followed by acute kidney failure 2-3 weeks later. The patient was managed with intravenous fluids and a low-salt, low-protein diet (92025).

Other ...In one case report, gynecomastia was observed in a male weightlifter taking an herbal combination product containing tribulus. However, it is not clear if this adverse effect can be attributed to tribulus alone (78859).

(Read more about TRIBULUS)