Vitomanhills 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 is interest in using oral Asparagus racemosus for anxiety, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition.
• Athletic performance. It is unclear if oral Asparagus racemosus is beneficial for improving athletic performance. Details: In recreationally trained males, taking Asparagus racemosus 500 mg daily for 8 weeks during bench press training increases the number of repetitions before exhaustion, and allows a greater increase in training loads, when compared with placebo (106413).
• Bronchitis. Although there is interest in using oral Asparagus racemosus for bronchitis, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition.
• Cancer. Although there is interest in using oral Asparagus racemosus for cancer, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this purpose.
• Dementia. Although there is interest in using oral Asparagus racemosus for dementia, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition.
• Diabetes. Although there is interest in using oral Asparagus racemosus for diabetes, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition.
• HIV/AIDS. Although there is interest in using oral Asparagus racemosus for HIV/AIDS, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition.
• Lactation. Oral Asparagus racemosus has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: In mothers who have to supplement their breast milk or who have infants with below normal weight gain, taking an herbal mixture containing Asparagus racemosus as 2 teaspoons twice daily for 4 weeks does not increase breast milk production, infant weight gain velocity, or prolactin levels (32588). Per 100 grams, the herbal mixture contained Asparagus racemosus 15 grams, dill 1 gram, morning glory 1 gram, licorice 2.5 grams, cumin 0.5 grams, and panchatrinamol 1 gram. Another small clinical study in postpartum mothers in India shows that consuming Asparagus racemosus in the form of 1 daily granola bar that contains Asparagus racemosus and other ingredients (Shavari Bar, Act Life Sciences Ltd.) for 4 days starting the day after delivery increases breast milk volume by about 15 mL and shortens the time to breast fullness when compared with placebo (111721). However, it is unclear whether any improvement is clinically significant, especially in the longer term. Additionally, the dose of Asparagus racemosus was not specified which limits the interpretation of these results.
• Muscle strength. It is unclear if oral Asparagus racemosus is beneficial for improving muscle strength. Details: A very small clinical study in physically active postmenopausal patients shows that taking Asparagus racemosus 1000 mg daily for 6 weeks improves hand grip strength, but not knee extensor strength, when compared with placebo (110736).
• Sexual desire. Although there is interest in using oral Asparagus racemosus for sexual desire, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this purpose.
• Tuberculosis. Although there is interest in using oral Asparagus racemosus for tuberculosis, there is insufficient reliable information about the clinical effects of Asparagus racemosus for this condition. More evidence is needed to rate Asparagus racemosus for these uses.

(Read more about ASPARAGUS RACEMOSUS)

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)

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 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 appropriately in healthy individuals. Asparagus racemosus 500 mg daily has been used with apparent safety for 8 weeks in male recreational athletes (106413).

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

(Read more about ASPARAGUS RACEMOSUS)

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)

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)

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)

DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, asparagus racemosus root might increase diuresis and electrolyte loss when used with diuretic drugs.  Details Animal studies show that asparagus racemosus root has diuretic effects when used in high doses (106417). This effect has not been reported in humans.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Probable •  Level of Evidence = D Theoretically, Asparagus racemosus root could reduce excretion and increase levels of lithium.  Details Animal research suggests that Asparagus racemosus root has diuretic properties when used in high doses (106417). Therefore, it might reduce excretion and increase levels of lithium. The dose of lithium might need to be decreased.

(Read more about ASPARAGUS RACEMOSUS)

(Read more about MACE)

(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.

(Read more about SHILAJIT)

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.

(Read more about ASHWAGANDHA)

General ...No adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about ASPARAGUS RACEMOSUS)

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.

(Read more about MACE)

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)