Nepalese Mineral Pitch • Tribulus terrestris • Boerhaavia • Cardamon • Commiphora Mukul • Emblica officinalis • Terminalia Chebula • Terminalia bellirica .
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Below is general information about the effectiveness of the known ingredients contained in the product Himalayan Diet Breakthrough. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
INSUFFICIENT RELIABLE EVIDENCE to RATE
Below is general information about the safety of the known ingredients contained in the product Himalayan Diet Breakthrough. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
LIKELY SAFE ...when used orally in amounts commonly found in foods. Cardamom has Generally Recognized as Safe (GRAS) status in the US (4912).
POSSIBLY SAFE ...when used orally in medicinal amounts, short-term. Cardamom powder 3 grams daily in 2-3 divided doses has been used with apparent safety for up to 16 weeks (95308,95597,101885,107920). ...when the essential oil is used by inhalation for aromatherapy (77054,95307).
PREGNANCY: LIKELY SAFE
when used orally in amounts commonly found in foods.
PREGNANCY: POSSIBLY UNSAFE
when used orally in medicinal amounts.
Cardamom is thought to have abortifacient and emmenagogue effects (19,39884). Avoid using amounts greater than those used in food.
LACTATION: LIKELY SAFE
when used orally in amounts commonly found in foods.
There is insufficient reliable information available about the safety of cardamom when used in medicinal amounts. Avoid using amounts greater than those used in food.
POSSIBLY SAFE ...when the prepared gum resin is used orally and appropriately. It has been used with apparent safety in clinical trials for up to 24 weeks (3267,3268,10371). There is insufficient reliable information available about the safety of guggul when used topically.
PREGNANCY: LIKELY UNSAFE
when used orally; avoid using.
Guggul gum resin appears to stimulate menstrual flow and the uterus (12).
LACTATION:
Insufficient reliable information available; avoid using.
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.
POSSIBLY SAFE ...when used orally and appropriately, short-term. Several small studies have used Terminalia arjuna powdered bark or bark extract with apparent safely in doses up to 2000 mg or 400 mg daily, respectively, for 2 weeks to 3 months (2502,2503,2504,111012,111093); however, patients should avoid self-treatment with this product due to potentially significant cardiovascular effects. Further study is needed to determine the safety of Terminalia arjuna for long-term use.
PREGNANCY AND LACTATION:
Insufficient reliable information available; avoid using.
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.
Below is general information about the interactions of the known ingredients contained in the product Himalayan Diet Breakthrough. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
Theoretically, guggul might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.
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Theoretically, guggul might increase the risk of adverse effects when taken with contraceptive drugs.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might reduce the effects of CYP3A4 substrates.
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In vitro research shows that guggul constituents known as guggulsterones can induce CYP3A4 (12444).
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Guggul might reduce the effects of diltiazem.
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A small pharmacokinetic study shows that concomitant use of guggul with diltiazem reduces the bioavailability of diltiazem (383).
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Theoretically, guggul might increase the risk of adverse effects when taken with estrogens.
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In vitro research shows that guggul constituents known as guggulsterones have estrogen-alpha receptor agonist activity (12444).
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Guggul might reduce the effects of propranolol.
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A small pharmacokinetic study shows that concomitant use of guggul with propranolol reduces the bioavailability of propranolol (383).
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Theoretically, guggul might increase the effects and adverse effects of rosuvastatin.
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Animal research shows that guggul increases the bioavailability and hypolipidemic effects of rosuvastatin (109584). The mechanism of this interaction is unclear.
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Theoretically, guggul might interfere with tamoxifen therapy.
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In vitro research shows that guggul has estrogen-alpha receptor agonist activity (12444).
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Theoretically, guggul might increase the risk for adverse effects when taken with thyroid hormone therapy.
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Animal research suggests that guggul has thyroid-stimulating effects (8153).
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Theoretically, Indian gooseberry may increase the risk of bleeding if used with anticoagulant or antiplatelet drugs; however, research is conflicting.
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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.
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Taking Indian gooseberry with antidiabetes drugs might increase the risk of hypoglycemia.
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Theoretically, Indian gooseberry may increase the risk of bleeding if used with aspirin; however, research is conflicting.
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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).
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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).
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Theoretically, concomitant use of Terminalia arjuna with anticoagulant or antiplatelet drugs may increase the risk of bleeding in some patients.
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In vitro, Terminalia arjuna bark extract inhibits platelet aggregation, decreases platelet activation, and shows antithrombotic properties (92831).
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Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2C9 substrates.
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In vitro research shows that Terminalia arjuna extract inhibits CYP2C9 enzymes and reduces CYP2C9 substrate metabolism (96729).
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Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2D6 substrates.
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In vitro research shows that Terminalia arjuna extract inhibits CYP2D6 enzymes and reduces CYP2D6 substrate metabolism (96729).
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Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP3A4 substrates.
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In vitro research shows that Terminalia arjuna extract inhibits CYP3A4 enzymes and reduces CYP3A4 substrate metabolism (96729).
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Taking tribulus with antidiabetes drugs might increase the risk of hypoglycemia.
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Clinical research shows that Tribulus can lower blood glucose levels in adults with type 2 diabetes who are taking antidiabetes medications (97327).
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Theoretically, taking tribulus with antihypertensive drugs might increase the risk of hypotension.
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Theoretically, tribulus might increase the levels and clinical effects of lithium.
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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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Below is general information about the adverse effects of the known ingredients contained in the product Himalayan Diet Breakthrough. Some ingredients may not be listed. This information does NOT represent a recommendation for or a test of this specific product as a whole.
General ...Orally, cardamom seems to be well tolerated.
Dermatologic ...Orally, mild skin inflammation due to cardamom has been reported in one participant of a clinical trial (101887). Topically, a case report describes chronic hand dermatitis in a confectioner frequently exposed to cardamom. Skin patch tests were positive for cardamom, and for terpenoids present in the seeds (39875).
Genitourinary ...Orally, dysuria due to cardamom has been reported in one participant of a clinical trial (101887). Also, a case report describes a 5-year-old female who developed hematuria after eating ice cream flavored with cardamom. It resolved spontaneously and there was no re-challenge (95306). It is not clear if cardamom is the direct cause of hematuria in this case.
General
...Orally, guggul seems to be generally well tolerated.
Most Common Adverse Effects:
Orally: Belching, bloating, diarrhea, headache, nausea, unpleasant taste, and vomiting. Allergic and non-allergic skin reactions.
Topically: Allergic contact dermatitis in sensitive individuals.
Serious Adverse Effects (Rare):
Orally: Rhabdomyolysis.
Dermatologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
Guggul can also cause nonallergic adverse skin reactions. The risk of skin reactions appears to be dose-dependent. In one study, the incidence of skin reactions was 3% with a dosage of 1000 mg three times daily, compared with 15% with a dosage of 2000 mg three times daily. The severity of the reactions ranged from pruritus to swelling and erythema of the face to bullous lesion on the lower legs associated with headaches, myalgias, and pruritus (13662).
Topically, guggul can cause allergic contact dermatitis (54464,54467). Also, in a small clinical study, one patient using a cream containing aqueous extracts of guggul and Allium ampeloprasum as well as sesame oil complained of rash at the application site (105751). It is unclear if this reaction was due to guggul, other ingredients, or other factors.
Gastrointestinal ...Orally, guggul can cause nausea, vomiting, loose stools, diarrhea, belching, bloating, hiccups, and mild gastrointestinal discomfort (3267,8155,8158,10371,52033,54492).
Hepatic ...A case of severe hypertransaminasemia has been reported for a 63-year-old female who took a specific product (Equisterol) containing guggulsterone and red yeast rice extract daily for 6 months. Liver function normalized after discontinuing the supplement. It is unclear if the adverse effect was due to guggulsterone, red yeast, or the combination. However, the patient had previously developed hepatotoxicity while taking lovastatin, and red yeast contains monacolin K, which is identical to lovastatin (54477). Also, a case of acute liver failure requiring liver transplantation has been reported for a previously healthy young female who used a mixed-ingredient dietary supplement containing extracts of green tea, guggul, and usnic acid. It is unclear if the hepatotoxicity was due to guggul or other ingredients; green tea has been associated with hepatotoxicity (54027).
Immunologic
...Orally, guggul can cause hypersensitivity reactions including rash and pruritus (10371,54457).
In a small clinical study, two adults with hyperlipidemia developed a hypersensitivity rash, one with facial edema, within minutes of oral administration of a methanolic extract of guggul, together with Terminalia extract (105741). It is unclear if this reaction was due to guggul, Terminalia, or other factors.
Topically, guggul can cause allergic contact dermatitis (54464,54467).
Musculoskeletal ...There is one case of rhabdomyolysis reported in a patient who took guggul 300 mg three times daily. The patient developed hemoglobinuria within 2 weeks of starting guggul in addition to increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase, creatine kinase, and myoglobinemia. The patient did not have any muscular symptoms. The patient's condition improved when guggul was discontinued. The patient had a history of developing elevated creatine kinase levels after taking simvastatin; however, the patient was not taking a statin at the time of this episode of rhabdomyolysis (13029).
Neurologic/CNS ...Orally, guggul can cause headaches (3267,8155,8158,10371,42692,49583). Less commonly, guggul may cause restlessness and apprehension (49583,54492).
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).
General ...There is currently a limited amount of information available on the adverse effects of oral Terminalia arjuna. A thorough evaluation of safety outcomes has not been conducted.
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).