Dashamula Powder by Banyan Botanicals

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Clinical research in patients with asthma shows that taking 100 mg of a specific product (AlvioLife) containing a 1:1 combination of bael fruit and boswellia gum resin extracts twice daily for 8 weeks improves activity, asthma symptoms, and emotions compared with placebo. The improvement in the maximum speed of expiration was approximately double that of placebo. The amount of air exhaled during a forced breath was not improved (99299). It is unclear if these effects are due to bael, boswellia, or the combination.
• Shigellosis. Preliminary clinical research shows that taking dried bael fruit powder 6 grams daily for 3 days does not reduce the number of stools in patients with diarrhea due to shigellosis (33330). More evidence is needed to rate bael for these uses.

(Read more about BAEL)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Although there has been interest in using oral jimson weed for asthma, there is insufficient reliable information about the clinical effects of jimson weed for this purpose.
• Bronchitis. Although there has been interest in using oral jimson weed for bronchitis, there is insufficient reliable information about the clinical effects of jimson weed for this purpose.
• Cough. Although there has been interest in using oral jimson weed for cough, there is insufficient reliable information about the clinical effects of jimson weed for this purpose.
• Influenza. Although there has been interest in using oral jimson weed for influenza, there is insufficient reliable information about the clinical effects of jimson weed for this purpose. More evidence is needed to rate jimson weed for these uses.

(Read more about JIMSON WEED)

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

(Read more about STEREOSPERMUM)

POSSIBLY EFFECTIVE

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

POSSIBLY INEFFECTIVE

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

INSUFFICIENT RELIABLE EVIDENCE to RATE

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

(Read more about TRIBULUS)

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

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

(Read more about BAEL)

UNSAFE ...when the leaf or seed are used orally or via inhalation (13,5622). Although all parts of the jimson weed plant contain toxic belladonna alkaloids, the seeds contain the highest quantity (5623). Ingestion of jimson weed can cause acute anticholinergic poisoning and death (17,5621,5622). The lethal dose for adults is 15-100 grams of jimson weed leaf or 15-25 grams of the seeds (equivalent to 100 mg atropine) (18).

CHILDREN: UNSAFE
when the seed or leaf are used orally or via inhalation. Although all parts of the jimson weed plant contain toxic belladonna alkaloids, the seeds contain the highest quantity (5623). Ingestion of jimson weed can cause acute anticholinergic poisoning and death (17,5621,5622). Children are more sensitive to the toxic effects of jimson weed than adults, and the lethal dose is lower (18). The lethal dose in children is less than 1.5-10 grams of jimson weed leaf or less than 1.5-2.5 grams of the seeds (equivalent to 10 mg or less of atropine) (57144).

PREGNANCY AND LACTATION: UNSAFE
when used orally (2); avoid using.

(Read more about JIMSON WEED)

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

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

(Read more about STEREOSPERMUM)

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

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

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about TRIBULUS)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Evidence from animal research suggests that extracts of bael seed and leaf can reduce blood glucose levels (33316,33325). Theoretically, bael might have additive effects with antidiabetes drugs and increase the risk of hypoglycemia. Monitor blood glucose levels closely. Dose adjustments might be necessary.  Details Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, pioglitazone (Actos), rosiglitazone (Avandia), and others.

CHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Bael leaf extract shows acetylcholinesterase (AChE) inhibitory activity in vitro (99296). Theoretically, bael might have additive effects with cholinergic drugs and increase the risk of cholinergic side effects.  Details Cholinergic drugs include bethanechol (Urecholine), donepezil (Aricept), echothiophate (Phospholine Iodide), edrophonium (Enlon, Reversol, Tensilon), neostigmine (Prostigmin), physostigmine (Antilirium), pyridostigmine (Mestinon, Regonol), succinylcholine (Anectine, Quelicin), and tacrine (Cognex).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Bael extract and its constituent marmesinin inhibited cytochrome P450 1A2 (CYP1A2) activity in vitro (99300). So far, this interaction has not been reported in humans. Theoretically, bael might increase levels of drugs metabolized by CYP1A2.  Details Some drugs metabolized by CYP1A2 include amitriptyline (Elavil), haloperidol (Haldol), ondansetron (Zofran), propranolol (Inderal), theophylline (Theo-Dur, others), verapamil (Calan, Isoptin, others), and others. Use bael cautiously or avoid in patients taking these drugs.

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Bael and its constituents marmelosin and marmesinin inhibited cytochrome P450 3A4 (CYP3A4) activity in vitro (99300). So far, this interaction has not been reported in humans. Theoretically, bael might increase levels of drugs metabolized by CYP3A4.  Details Some drugs metabolized by CYP3A4 include lovastatin (Mevacor), ketoconazole (Nizoral), itraconazole (Sporanox), fexofenadine (Allegra), triazolam (Halcion), and numerous others. Use bael cautiously or avoid in patients taking these drugs.

(Read more about BAEL)

ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, jimson weed may increase anticholinergic effects and adverse effects.  Details Jimson weed contains alkaloids with anticholinergic effects, such as atropine and scopolamine. Use with other anticholinergic drugs may cause additive effects (2,506,57079,57092,57123,57146,57147).

(Read more about JIMSON WEED)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Animal research suggests that stereospermum can have hypoglycemic effects (88136,88139). This has not been shown in humans. Until more is known, use cautiously in patients taking antidiabetes drugs. Theoretically, concomitant use with antidiabetes drugs might affect glucose control and increase the risk of hypoglycemia.  Details Some antidiabetes drugs include glimepiride (Amaryl), glyburide (DiaBeta, Glynase PresTab, Micronase), insulin, metformin (Glucophage), pioglitazone (Actos), rosiglitazone (Avandia), and others.

(Read more about STEREOSPERMUM)

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

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

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

(Read more about TRIBULUS)

General ...Consuming large amounts of bael may cause gastrointestinal upset and constipation (18).

Gastrointestinal ...Orally, consuming large amounts of bael may cause gastrointestinal upset and constipation (18).

(Read more about BAEL)

General ...Orally, jimson weed is unsafe.
Most Common Adverse Effects:
Orally: Anticholinergic effects, such as abdominal pain, altered mental status, dry eyes, dry mouth, dry skin, nausea, tachycardia, urinary retention, and vomiting.
Serious Adverse Effects (Rare):
Orally: Anticholinergic toxicity, death.

Cardiovascular ...Orally, jimson weed can cause anticholinergic side effects such as hypertension, tachycardia, and arrhythmia (57099,57156,57067,57103,57151,57152,57129,109502).

Dermatologic ...Orally, jimson weed can cause anticholinergic side effects such as dry, red, flushed, or hot skin and decreased perspiration (57089,57146).

Gastrointestinal ...Orally, jimson weed can cause anticholinergic side effects such as abdominal pain, nausea and vomiting, decreased bowel sounds, and difficulty swallowing (13,18,5623,109502).

Genitourinary ...Orally, jimson weed can cause anticholinergic side effects such as urinary retention (57129,57152,57151,109502).

Hematologic ...Orally, jimson weed has been reported to cause thrombocytopenia in one patient (109502).

Hepatic ...Orally, jimson weed can cause hepatotoxic events, including fulminant hepatitis (57091).

Musculoskeletal ...Orally, jimson weed can cause anticholinergic side effects such as leg cramps, muscle tremor, and muscle rigidity (57089,57146).

Neurologic/CNS ...Orally, jimson weed can cause anticholinergic side effects such as memory loss, attention impairment, confusion, hallucinations, slurred speech, psychosis, agitated delirium, seizures, and coma (57067,57075,57077,57078,57084,57085,57098,57103)(57108,57116,57120,57140,57148)(57151,57152,57156,109502).

Ocular/Otic ...Orally, jimson weed can cause anticholinergic side effects such as blurred vision and mydriasis (57120,57133,57151,57151,57116,57121,109502). Topically, direct exposure of the eye to jimson weed alkaloids can also cause mydriasis (57061).

Other ...Orally, jimson weed can block muscarinic cholinergic neurons and cause anticholinergic side effects. Larger amounts of jimson weed intake can also lead to toxicity and anticholinergic syndrome. Central anticholinergic symptoms, which are dose-dependent, include muscle tremor and rigidity, leg cramps, hallucinations, slurred speech, psychosis, agitated delirium, seizures, coma, cardiovascular collapse, or respiratory failure. Peripheral anticholinergic symptoms include dilated pupils, blurry vision, dry mouth, flushed skin, tachycardia, arrhythmias, fever, hypertension or hypotension, and difficulty urinating (636,57067,57075,57077,57078,57084,57085,57098,57103)(57108,57116,57120,57140,57148)(57151,57152,57156). There are also numerous reports of death after jimson weed ingestion (5622,57067,57086,57088,109503). The lethal dose of jimson weed for adults is 15-100 grams of leaf or 15-25 grams of the seeds (equivalent to 100 mg atropine) (18). Jimson weed toxicity seems to occur 1-12 hours after ingestion (57084,57092,109502).
Children and adolescents are more susceptible to jimson weed toxicity. The lethal dose of atropine in this population is 10 mg or less. There are numerous case reports of anticholinergic toxicity in children and adolescents ingesting jimson weed seeds accidentally and recreationally (57098,57129,57144,95448,95449,95450,95451,95452). Some children ingested leaves that were packed into jimson weed cigarettes; others ingested several hundred seeds (57116).

(Read more about JIMSON WEED)

General ...Orally or topically, no adverse effects have been reported. However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about STEREOSPERMUM)

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

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

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

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

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

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

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

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

(Read more about TRIBULUS)