Moringa Pure 4X Extract by Shape Organics

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.

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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.

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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.

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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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