Liver Formula [Discontinued] by Banyan Botanicals

POSSIBLY EFFECTIVE

• Common cold. Oral andrographis, taken alone or as part of a specific combination product (Kan Jang, Swedish Herbal Institute) also containing eleuthero, seems to improve symptoms of the common cold. It is unclear if oral andrographis is beneficial for preventing the common cold. Details: Most clinical research shows that taking andrographis alone or as part of a combination herbal supplement improves cold symptoms (2744,2773,2774,5784,10795,12380,12381,98222). Taking a specific combination product (Kan Jang, Swedish Herbal Institute) containing andrographis extract, standardized to andrographolides 4-5.6 mg, and eleuthero three times daily seems to improve symptoms of the common cold when started within 72 hours of symptom onset. Some symptoms can improve after 2 days of treatment, but it typically takes 4-5 days of treatment for maximal symptom relief (2744,2773,2774,5784,10795,12380). This combination also seems to relieve cold symptoms better than echinacea or placebo in children (12381). Other clinical research shows that taking a specific andrographis extract (KalmCold) 200 mg daily for 5 days reduces cold symptoms by approximately two-fold and increases the number of patients who respond to treatment when compared with placebo (31222). Preliminary clinical research shows that taking andrographis (Kan Jang, Swedish Herbal Institute) prophylactically might decrease the risk of developing a cold by about 50% after 2 months of continuous treatment (2772); however, more evidence is needed to confirm these results.
• Osteoarthritis. Oral andrographis extract has been evaluated for the treatment of osteoarthritis, with promising results. Details: In patients with mild to moderate osteoarthritis of the knee, clinical research shows that taking a specific brand of andrographis extract (ParActin, HP Ingredients) 300 mg and 600 mg daily for 12 weeks reduces pain and stiffness by approximately 40% and 46%, respectively, compared with changes of less than 10% with placebo (101116).
• Tonsillopharyngitis. Oral andrographis has been evaluated for the management of fever and sore throat associated with tonsillopharyngitis, with promising results. Details: Some clinical research shows that andrographis 6 grams daily is comparable to acetaminophen for reducing fever and sore throat associated with tonsillopharyngitis after 3 and 7 days of treatment (2748).
• Ulcerative colitis. Oral andrographis extract has been evaluated for the management of ulcerative colitis symptoms, with promising results. Details: Some clinical research shows that taking andrographis extract 1200-1800 mg daily for 8 weeks reduces symptoms of mild to moderate ulcerative colitis, but does not affect remission rates, when compared with placebo (31231). Additional clinical research also shows that taking andrographis extract 1200 mg daily for 8 weeks is as effective as mesalamine for reducing symptoms in patients with ulcerative colitis (31223).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Acute bronchitis. Although there has been interest in using oral andrographis for acute bronchitis, there is insufficient reliable information about the clinical effects of andrographis for this purpose.
• Cognitive impairment. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in a small number of patients with mild cognitive impairment shows that taking a combination product (Adaptra Forte, Europharma USA) containing andrographis extract 400 mg, standardized to andrographolides 40 mg, and ashwagandha extract 150 mg twice daily for 4 weeks modestly improves some measures of concentration and sleep quality when compared with placebo (104822).
• Coronavirus disease 2019 (COVID-19). It is unclear if oral andrographis is beneficial in mild to moderate COVID-19. Details: A moderate-sized clinical study in adults with mild to moderate COVID-19 receiving standard of care conducted in India shows that taking andrographis raw plant part extract 200 mg twice daily for 14 days improves the time to clinical improvement by 2-points on the World Health Organization (WHO) scale to about 4 days compared with about 6 days in the control group (112920). However, the interpretation of this finding is limited by unbalanced groups with sicker patients in the control group. Additionally, a large observational study conducted in Thailand in unvaccinated hospitalized adults with mild COVID-19 suggests that taking andrographis, dosed as andrographolide 60 mg, three times daily for 5 days is not associated with a decrease in the risk of developing pneumonia when compared with standard of care (112919).
• Diabetes. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical trial in adults with type 2 diabetes who are taking metformin 1000 mg daily shows that taking a combination product containing andrographis and Syzygium polyanthum leaf extracts, 900 mg daily for 8 weeks, does not improve fasting blood glucose levels, glycated hemoglobin (HbA1c), blood pressure, or blood lipid levels when compared with placebo (101117).
• Familial Mediterranean fever. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in children 3-15 years of age shows that taking a combination product (ImmunoGuard, Inspired Nutritionals) containing andrographis 16 mg, eleuthero, schisandra, and licorice daily for 1 month reduces the duration, frequency, and severity of attacks of familial Mediterranean fever (12382).
• Hypertriglyceridemia. It is unclear if oral andrographis is beneficial in patients with hypertriglyceridemia. Details: A small clinical study in adults with hypertriglyceridemia shows that taking andrographis, standardized to contain andrographolide 119.64-120.36 mg, by mouth daily for 8 weeks decreases triglycerides by 42 mg/dL, demonstrating comparable effects to gemfibrozil. However, compared to baseline, total cholesterol was increased by 15 mg/dL and low-density lipoprotein (LDL) cholesterol was increased by 21 mg/dL, suggesting that the benefits of lower triglycerides may be offset by elevations in other lipid levels. Taking a lower daily dose of andrographis, standardized to contain andrographolide 71.64-72.36 mg, does not seem to affect lipid levels (91839).
• Impaired glucose tolerance (prediabetes). It is unclear if oral andrographis is beneficial in patients with prediabetes. Details: A small crossover clinical study in adults with prediabetes conducted in Indonesia shows that taking andrographis 550 mg for 14 days increases glucagon-like peptide 1 (GLP-1) levels but does not statistically improve measures of insulin resistance (i.e., fasting insulin, fasting glucose, 2-hour postprandial glucose, 2-hour postprandial insulin, homeostatic model assessment for insulin resistance [HOMA-IR]) when compared with placebo (112918). However, it is unclear whether this improvement is clinically significant. In addition, the frequency of andrographis dosing is unclear.
• Influenza. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research shows that patients with influenza who take a specific product (Kan Jang, Swedish Herbal Institute) containing andrographis extract, standardized to andrographolides 4-5.6 mg, and eleuthero three times daily for 3-5 days have more rapid symptom relief when compared with patients taking amantadine. Taking this combination product also seems to reduce the risk of post-influenza complications such as rhinosinusitis or bronchitis when compared with amantadine (10441).
• Migraine headache. Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Research has evaluated a combination product (Vivinor, Brain Therapeutics; Partena, FB Health) containing andrographis 100 mg, magnesium 281 mg, riboflavin 5 mg, feverfew 150 mg, and coenzyme Q10 20 mg. A nonblinded, clinical study in patients with episodic migraines shows that taking 1-2 tablets of this product daily for 3 months decreases monthly average migraine days, migraine severity, and the number of days an acute migraine medication is used when compared with baseline. In the third month of treatment, 57% of patients had at least a 50% reduction in average migraine days (107473). The validity of this study is limited by the lack of randomization and placebo-control; additionally, it is unclear if any effects are due to andrographis, the other ingredients, or the combination.
• Multiple sclerosis (MS). It is unclear if oral andrographis is beneficial in patients with MS. Details: A small clinical study in patients with relapsing-remitting MS currently receiving interferon-beta shows that taking andrographis dried extract (Innobioscience Spa) 170 mg, standardized to contain andrographolides 85 mg, twice daily for 12 months decreases fatigue by 44%, but does not affect relapse rate or disability, when compared with placebo (91838). Another small clinical study of patients with primary or secondary, but not active, progressive MS shows that taking andrographolide, a constituent of andrographis, 140 mg twice daily for 24 months slows the progression of disability when compared with placebo (104821).
• Rheumatoid arthritis (RA). It is unclear if oral andrographis is beneficial in patients with RA. Details: Preliminary clinical research shows that taking andrographis extract 90 mg daily for 14 weeks reduces symptoms of RA when compared to baseline, but not when compared with placebo (31220).
• Rhinosinusitis. Although there has been interest in using oral andrographis for rhinosinusitis, there is insufficient reliable information about the clinical effects of andrographis for this purpose.
• Upper respiratory tract infection (URTI). Oral andrographis has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: One small clinical study in adults with uncomplicated URTI shows that a specific combination product (Kan Jang, Swedish Herbal Institute) containing andrographis 195 mg and eleuthero root 11.4 mg per capsule, taken as two capsules three times daily for 5 days, reduces the median number of sick leave days to 2 days, compared with 3 days in the placebo group. It also increases the total number of recovered patients on day 3 to 75%, compared with 55% of those taking placebo (107471). More evidence is needed to rate andrographis for these uses.

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POSSIBLY EFFECTIVE

• Kidney stones (nephrolithiasis). Although some research disagrees, most clinical research shows that taking chanca piedra might improve clearance and decrease the size of kidney stones. However, it seems that disease severity, stone location, and chanca piedra dose and/or formulation may alter the likelihood of benefit. Details: Preliminary clinical research in adults with kidney stones shows that taking a specific chanca piedra product (Uriston) 2 grams orally daily for up to 3 months after undergoing 1-3 extracorporeal shock wave lithotripsy sessions increases clearance of kidney stones within 30-60 days by 1-2 times that of control (41224). Other preliminary clinical research in patients with kidney stones smaller than 10 mm also shows that drinking a chanca piedra tea, prepared with 4.5 grams of dried extract in 250 mL boiled water, twice daily for 12 weeks decreases the number of kidney stones by 38% and kidney stone size by 40% when compared with baseline (99849). However, a small clinical trial in adults with kidney stones failed to demonstrate beneficial effects from chanca piedra extract 450 mg three times daily orally for 3 months (41202). Some subgroup and other analyses also suggest that chanca piedra may be more effective in patients with hyperoxaluria or hyperuricosuria at baseline or those with smaller kidney stones of less than 6 mm or 10 mm (41224,99849,102692). Preliminary clinical research also shows that, in patients taking chanca piedra leaf extract 225 mg with magnesium stearate 152 mg and vitamin B6 2 mg twice daily for 3 months, stone-free status occurs in about 55% of patients with middle or upper kidney stones and about 14% of those with lower stones when compared with baseline (102692).

LIKELY INEFFECTIVE

• Hepatitis B. Most clinical research shows that oral chanca piedra is not effective for treating hepatitis B. Details: Despite preliminary clinical research suggesting that chanca piedra may be beneficial in patients with hepatitis B (41287), multiple follow-up clinical trials show that taking chanca piedra 200-900 mg three times daily for 1-6 weeks is not effective for treating hepatitis B, decreasing the duration of acute hepatitis B, or decreasing levels of hepatitis B surface antigen (HBsAg) (3924,3925,41180,41242,41255,41259,41294,41318).

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Abdominal pain. Although there has been interest in using oral chanca piedra for abdominal pain, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Anemia of chronic disease. Although there has been interest in using oral chanca piedra for anemia of chronic disease, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Asthma. Although there has been interest in using oral chanca piedra for asthma, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Benign prostatic hyperplasia (BPH). Oral chanca piedra has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A small clinical study in adults with BPH, some of whom were already receiving treatment for their symptoms, shows that taking a specific product containing water-soluble extracts of chanca piedra, boldo, goldenrod, fireweed, and spiny restharrow (Fluxonorm, Omega Pharma) for 30 days improves lower urinary tract symptom scores by about 50% when compared with baseline. Maximum urinary flow rate and quality of life were also improved when compared with baseline (106432). The validity of these findings is limited by the lack of a comparator group.
• Colic. Although there has been interest in using oral chanca piedra for colic, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Diabetes. It is unclear if oral chanca piedra is beneficial in patients with diabetes. Details: Preliminary clinical research in patients with types 2 diabetes shows that taking chanca piedra extract 12.5 grams orally twice daily for 7 days does not affect fasting or postprandial blood glucose levels when compared with baseline. The extract was prepared as 25 grams boiled in 200 mL of water (41186). The validity of this study is limited by the lack of a comparator group.
• Gallbladder disease. Although there has been interest in using oral chanca piedra for gallbladder disease, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Gastric cancer. Although there has been interest in using oral chanca piedra for gastric cancer, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Gonorrhea. Although there has been interest in using oral chanca piedra for gonorrhea, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Hangover. It is unclear if oral chanca piedra is beneficial in patients with hangover. Details: Preliminary clinical research in a small number of healthy adults shows that taking a standardized extract of chanca piedra (PHYLLPRO, Biotropics Malaysia Berhad) 375 mg orally twice daily for 10 days prior to heavy alcohol consumption may improve alcohol clearance, but does not improve hangover symptom scores or mood scores, when compared with placebo (99846). However, the study may have been inadequately powered to detect a difference between groups.
• Hypertension. It is unclear if oral chanca piedra is beneficial in patients with hypertension. Details: Preliminary clinical research in patients with hypertension shows that taking chanca piedra 1.6 grams orally three times daily for 10 days does not reduce systolic or diastolic blood pressure when compared with baseline (3928). The validity of this study is limited by the lack of a comparator group.
• Intestinal parasite infection. Although there has been interest in using oral chanca piedra for intestinal parasite infection, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Lymphedema. Although there has been interest in using oral chanca piedra for lymphedema, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Malaria. Although there has been interest in using oral chanca piedra for malaria, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Miscarriage. Although there has been interest in using oral chanca piedra for miscarriage, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Osteoarthritis. It is unclear if topical chanca piedra is beneficial in patients with osteoarthritis. Details: Preliminary clinical research in patients with knee osteoarthritis shows that topical application of a chanca piedra gel with phonophoresis once daily for 10 days reduces pain and improves function when compared with placebo gel. Pain was reduced by 78%, compared with a reduction of 44% in those using the placebo gel, and patients using chanca piedra were able to walk 62 meters farther in 6 minutes when compared with placebo gel (102691).
• Premature ejaculation. Oral chanca piedra has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Clinical research in adults with premature ejaculation shows that taking a specific combination product containing chanca piedra, cardamom, vitamin B6, tribulus, tryptophan, thiamine, and winter savory (Eiacumev, Farmaceutica MEV) orally once daily for 3 months improves premature ejaculation severity scores and increases time to ejaculation when compared with sexual counseling. Time to ejaculation increased by around 30 seconds when compared with control (97016). The validity of this study is limited by the lack of randomization and placebo-control.
• Pruritus. Although there has been interest in using oral chanca piedra for pruritus, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Respiratory tract infections. Although there has been interest in using oral chanca piedra for respiratory tract infections, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Sexual dysfunction. Although there has been interest in using oral chanca piedra for sexual dysfunction, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Solid tumors. Although there has been interest in using oral chanca piedra for solid tumors, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Tonsillopharyngitis. Oral chanca piedra has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: Preliminary clinical research in patients with tonsillopharyngitis shows that taking chanca piedra 50 mg and black seed 360 mg orally three times daily for 7 days moderately relieves pain when compared with placebo (36199).
• Urinary tract infections (UTIs). Although there has been interest in using oral chanca piedra for UTIs, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Vaginitis. Although there has been interest in using oral chanca piedra for vaginitis, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose.
• Vertigo. Although there has been interest in using oral chanca piedra for vertigo, there is insufficient reliable information about the clinical effects of chanca piedra for this purpose. More evidence is needed to rate chanca piedra for these uses.

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POSSIBLY EFFECTIVE

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

INSUFFICIENT RELIABLE EVIDENCE to RATE

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

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INSUFFICIENT RELIABLE EVIDENCE to RATE

• Asthma. Although there has been interest in using oral Indian long pepper for asthma, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Bronchitis. Although there has been interest in using oral Indian long pepper for bronchitis, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Cancer. Although there has been interest in using oral Indian long pepper for cancer, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Cardiovascular disease (CVD). Although there has been interest in using oral Indian long pepper for CVD, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Cognitive function. Although there has been interest in using oral Indian long pepper for cognitive function, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Common cold. Although there has been interest in using oral Indian long pepper for the common cold, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Cough. Although there has been interest in using oral Indian long pepper for cough, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Depression. Although there has been interest in using oral Indian long pepper for depression, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Dyspepsia. Although there has been interest in using oral Indian long pepper for dyspepsia, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Epilepsy. Although there has been interest in using oral Indian long pepper for epilepsy, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Gastroesophageal reflux disease (GERD). Although there has been interest in using oral Indian long pepper for GERD, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Hypothyroidism. It is unclear if oral Indian long pepper is beneficial in patients with hypothyroidism. Details: A small, uncontrolled clinical study in adults with subclinical or overt hypothyroidism shows that taking Indian long pepper powder 0.69 grams daily for 19 days or following a dose escalating and deescalating regimen for 19 days improves some symptoms of hypothyroidism, as measured by Zulewski scores, but has little to no effect on thyroid hormone levels when compared to baseline. The dose escalating and deescalating regimen included 0.69 grams of Indian long pepper powder on day 1 which was titrated up to 6.9 grams by day 10 and then deescalated down to 0.69 grams by day 19 (111111). The validity of these findings is limited by the lack of a placebo control group.
• Liver disease. Although there has been interest in using oral Indian long pepper for liver disease, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Muscle soreness. Although there has been interest in using oral Indian long pepper for muscle soreness, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Osteoarthritis. Although there has been interest in using oral Indian long pepper for osteoarthritis, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Psoriasis. Although there has been interest in using oral Indian long pepper for psoriasis, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral Indian long pepper for RA, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Stress. Although there has been interest in using oral Indian long pepper for stress, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose.
• Tuberculosis. Although there has been interest in using oral Indian long pepper for tuberculosis, there is insufficient reliable information about the clinical effects of Indian long pepper for this purpose. More evidence is needed to rate Indian long pepper for these uses.

(Read more about INDIAN LONG PEPPER)

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

(Read more about MADDER)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Irritable bowel syndrome (IBS). A small clinical study shows that taking an herbal mixture containing purple nut sedge tuber, English horsemint, and ginger three times daily for 8 weeks improves IBS symptoms including abdominal pain, stool frequency, stool consistency, incomplete evacuation, and urgency, when compared to baseline. These improvements are similar to those achieved by taking the antispasmodic mebeverine 135 mg three times daily (89900). It is unclear if these effects are due to purple nut sedge, other ingredients, or the combination. More evidence is needed to rate the effectiveness of purple nut sedge for this use.

(Read more about PURPLE NUT SEDGE)

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Angina. It is unclear if oral Terminalia arjuna is beneficial in patients with angina. Details: Low-quality clinical research in patients with angina shows that taking Terminalia arjuna extract 500-2000 mg orally daily for 3 months reduces the frequency of angina symptoms by 50% to 71% when compared with baseline. These results were similar to taking conventional therapy (2502,2503). Other preliminary research in adults with chronic stable angina shows that taking Terminalia arjuna 500 mg orally three times daily for 7 days reduces the need for rescue treatment and improves exercise tolerance when compared with placebo. Improvements were similar to taking isosorbide mononitrate 20 mg twice daily (92833).
• Asthma. Although there has been interest in using oral Terminalia arjuna for asthma, there is insufficient reliable information about the clinical effects of Terminalia arjuna for this purpose.
• Athletic performance. It is unclear if oral Terminalia arjuna is beneficial for athletic performance. Details: A small clinical study in young regular exercising males shows that taking Terminalia arjuna extract (Oxyjun, Enovate Biolife Pvt Ltd, India) 400 mg daily for 8 weeks increases the time to exhaustion by approximately 117 seconds when compared with placebo. There were also modest improvements in feelings of perceived exertion and the left ventricular ejection fraction, a measure of blood pumped from the heart with each heartbeat (111093). It is unclear if oral Terminalia arjuna is beneficial other populations such as athletes and females.
• Coronary heart disease (CHD). It is unclear if oral Terminalia arjuna is beneficial in patients with CHD. Details: Preliminary clinical research in patients with CHD shows that taking Terminalia arjuna bark powder 500 mg orally daily for 30 days decreases levels of total cholesterol by about 10% and low-density lipoprotein (LDL) cholesterol by about 16% when compared with baseline. Taking Terminalia arjuna bark powder did not improve high-density lipoprotein (HDL) cholesterol levels (92832).
• Heart failure. The effects of Terminalia arjuna in patients with heart failure is unclear; evidence to date comes from small, short-term clinical studies, and results are conflicting. Details: Preliminary, low-quality clinical research in patients with severe, refractory congestive heart failure shows that taking Terminalia arjuna bark extract 500 mg orally three times daily for 2 weeks, as an adjunct to conventional therapy, improves left ventricular ejection fraction (LVEF) by 17% when compared with placebo (2504). However, other preliminary clinical research in adults with stage II heart failure shows that taking an extract of Terminalia arjuna bark 750 mg orally twice daily as an adjunct to conventional therapy for 12 weeks does not improve LVEF, functional class, or functional capacity when compared with placebo (96726). However, the validity of these trials is limited by short-term treatment and variation in the conventional therapies used to manage heart failure.
• Hyperlipidemia. It is unclear if oral Terminalia arjuna is beneficial for improving lipid levels. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors, such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days decreases levels of low-density lipoprotein (LDL) cholesterol and triglycerides by 17% and 35%, respectively, and increases high-density lipoprotein (HDL) cholesterol levels by 9%, when compared with baseline. Improvements in lipid parameters were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). However, this study may have been inadequately powered to detect a difference between groups.
• Hypertension. It is unclear if oral Terminalia arjuna is beneficial for reducing blood pressure. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days reduces systolic and diastolic blood pressure by 11% and 14%, respectively, when compared with baseline. Improvements in blood pressure were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). However, this study may have been inadequately powered to detect a difference between groups.
• Obesity. It is unclear if oral Terminalia arjuna is beneficial for weight loss. Details: Preliminary clinical research in patients with elevated cardiovascular risk factors, such as hypertension, dyslipidemia, or obesity, shows that taking Terminalia arjuna 5 grams orally twice daily for 60 days reduces body mass index (BMI) by 6% when compared with baseline. Improvements in BMI were similar to taking amlodipine 5 mg and atorvastatin 10 mg daily (109677). This study may have been inadequately powered to detect a difference between groups. More evidence is needed to rate Terminalia arjuna for these uses.

(Read more about TERMINALIA ARJUNA)

POSSIBLY EFFECTIVE

• Diabetes. Oral Tinospora cordifolia seems to reduce glycated hemoglobin and fasting blood glucose in adults with type 2 diabetes. Details: A meta-analysis of 2 moderate-sized clinical trials in adults with type 2 diabetes shows that taking Tinospora cordifolia extract 500 mg or 1500 mg daily for 9 or 26 weeks, respectively, reduces glycated hemoglobin by 0.5% when compared with no additional medicine. Additionally, meta-analysis of 2 small to moderate-sized clinical trials in adults with type 2 diabetes shows that taking Tinospora cordifolia extract 1500 mg daily for 26 weeks as tablets or as a decoction 5 mL daily for 9 weeks reduces fasting blood glucose by 4 mg/dL when compared with placebo or no additional medicine (111503). However, all studies were conducted in India; it is unclear if these findings can be extrapolated to other geographic locations.

INSUFFICIENT RELIABLE EVIDENCE to RATE

• Allergic rhinitis (hay fever). It is unclear if oral Tinospora cordifolia extract is beneficial in patients with allergic rhinitis. Details: One small clinical trial in patients with allergic rhinitis shows that taking a specific Tinospora cordifolia aqueous stem extract (Tinofend, Verdure Sciences) 300 mg three times daily for 8 weeks decreases sneezing, as well as nasal itching, discharge, and obstruction, when compared with placebo (15085).
• Asthma. Although there has been interest in using oral Tinospora cordifolia for asthma, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Athletic performance. It is unclear if oral Tinospora cordifolia extract is effective for improving athletic performance. Details: One small clinical study in healthy males shows that taking Tinospora cordifolia stem powdered extract 150-300 mg daily for 28 days improves speed during cycling and hand grip strength when compared to baseline; however, these improvements are not significant when compared with placebo (92230).
• Cancer. Although there has been interest in using oral Tinospora cordifolia for cancer, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Coronavirus disease 2019 (COVID-19). Although there has been interest in using oral Tinospora cordifolia for COVID-19, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Diabetic foot ulcers. It is unclear if oral Tinospora cordifolia is beneficial in patients with diabetic foot ulcers. Details: One small clinical study in patients with diabetic foot ulcers shows that taking Tinospora cordifolia extract (dose unknown), in conjunction with standard treatment, for one month reduces the total number of debridements by 24% and the extent of phagocytosis in the wound when compared with placebo plus standard treatment. However, Tinospora cordifolia does not appear to improve the wound severity, size, or depth when compared with placebo (92227).
• Gout. Although there has been interest in using oral Tinospora cordifolia for gout, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Hepatitis. Although there has been interest in using oral Tinospora cordifolia for hepatitis, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Hyperlipidemia. Although there has been interest in using oral Tinospora cordifolia for hyperlipidemia, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Hypertriglyceridemia. It is unclear if oral Tinospora cordifolia extract is beneficial in patients with hypertriglyceridemia. Details: One small clinical study in patients with hypertriglyceridemia shows that taking Tinospora cordifolia stem extract 3 grams daily for 14 days reduces levels of triglycerides and low-density lipoprotein (LDL) cholesterol by around 170 mg/dL and 25 mg/dL, respectively, while increasing high-density lipoprotein (HDL) cholesterol levels by 12 mg/dL when compared to baseline. Patients in a control group taking metformin saw smaller improvements in these lipid levels, although a statistical comparison between Tinospora cordifolia and metformin was not reported (106846).
• Osteoarthritis. Oral Tinospora cordifolia has only been evaluated in combination with other ingredients; its effect when used alone is unclear. Details: A large clinical study in adults with osteoarthritis shows that taking a specific Ayurvedic formulation (shunthi-guduchi) containing Tinospora cordifolia 440 mg, Indian gooseberry 1000 mg, and ginger 200 mg, with or without Boswellia serrata 600 mg, in divided doses daily for 24 weeks improves pain and functionality as effectively as celecoxib or glucosamine sulfate (89557). However, the clinical validity of these results is limited by the lack of a placebo control. Also, it is unclear if these findings are due to Tinospora cordifolia, other ingredients, or the combination.
• Peptic ulcers. Although there has been interest in using oral Tinospora cordifolia for peptic ulcers, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Rheumatoid arthritis (RA). Although there has been interest in using oral Tinospora cordifolia for RA, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose.
• Scabies. It is unclear if topical Tinospora cordifolia lotion is beneficial in patients with scabies. Details: One small clinical study in children and young adults shows that topical application of Tinospora cordifolia lotion 3 days weekly for 2 weeks is as effective as permethrin 5% lotion for clearing the symptoms of scabies. At 28 days from the initiation of treatment, complete cure occurs in 70% of patients applying Tinospora cordifolia, compared with 50% of patients applying permethrin (92220).
• Sexual desire. Although there has been interest in using oral Tinospora cordifolia for increasing sexual desire, there is insufficient reliable information about the clinical effects of Tinospora cordifolia for this purpose. More evidence is needed to rate Tinospora cordifolia for these uses.

(Read more about TINOSPORA CORDIFOLIA)

LIKELY SAFE ...when used orally and appropriately, short-term. Andrographis has been used with apparent safety in doses of up to 6 grams daily for up to 7 days. Andrographis extract has been used with apparent safety at doses of up to 340 mg daily for up to 12 months, 600 mg daily for up to 3 months, or 1200 mg daily for up to 8 weeks (2748,31220,31223,31231,91838,91839,101116). Andrographolide, a constituent of andrographis, has been used with apparent safety at a dose of 280 mg daily for 24 months (104821). A specific combination product containing andrographis extract 178-206 mg and eleuthero (Kan Jang, Swedish Herbal Institute) has been taken three times daily with apparent safety for up to 4-7 days (2744,2748,2773,2774,10441,10795,13016).

CHILDREN: POSSIBLY SAFE
when used orally and appropriately, short-term. Andrographis, in combination with other herbs, has been used with apparent safety in clinical trials at doses up to 48 mg daily in children 3-15 years of age for up to one month (12381,12382).

PREGNANCY: POSSIBLY UNSAFE
when used orally. Andrographis is thought to have abortifacient effects (12); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about ANDROGRAPHIS)

POSSIBLY SAFE ...when taken orally in doses of up to 2 grams daily for up to 3 months (3924,3928,41180,41186,41224,41287,41294,41318,98846,107946). There is insufficient reliable information available about the safety of chanca piedra when used topically.

PREGNANCY: POSSIBLY UNSAFE
when used during pregnancy or in those trying to become pregnant. Animal research shows that chanca piedra, particularly at high doses, may have contraceptive effects or may increase the risk of low birth weight or birth defects (41183,41316,41317); avoid using.

LACTATION:
Insufficient reliable information available; avoid using.

(Read more about CHANCA PIEDRA)

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

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

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

(Read more about INDIAN GOOSEBERRY)

LIKELY SAFE ...when used orally in food amounts. The fruit is commonly used in foods (101151). There is insufficient reliable information available about the safety of Indian long pepper when used in medicinal amounts.

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

(Read more about INDIAN LONG PEPPER)

LIKELY UNSAFE ...when used orally. It is potentially carcinogenic and mutagenic (2,18,19). There is insufficient reliable information available about the safety of madder when used topically.

PREGNANCY: UNSAFE
when used orally because it may be a potential menstrual stimulant and a genotoxin (2,19).

LACTATION: UNSAFE
when used orally because it is a potential genotoxin (2,19). It also can cause red-colored breast milk (2).

(Read more about MADDER)

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.

(Read more about TERMINALIA ARJUNA)

POSSIBLY SAFE ...when the stem extract is used orally and appropriately, short-term. Tinospora cordifolia aqueous stem extract has been used with apparent safety at a dose of 900 mg daily for up to 8 weeks (15085). Powdered stem extract has also been used with apparent safety at a dose of up to 3 grams daily for up to 2 weeks or a dose of 1500 mg daily for up to 26 weeks (92230,106846,111503). There is insufficient reliable information available about the safety of other parts of Tinospora cordifolia when used orally or when any part of the plant is used topically.

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

(Read more about TINOSPORA CORDIFOLIA)

ACECLOFENAC Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and decrease the area under the curve of aceclofenac. The clinical significance of these changes is unclear.  Details Animal research suggests that andrographis extract taken orally increases the maximum concentration and decreases the area under the curve of aceclofenac (112916).

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might increase the risk of bleeding when used with anticoagulant or antiplatelet drugs.  Details Animal and laboratory studies suggest that andrographis has antiplatelet effects (2758,2759).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might increase the risk of hypotension when used with antihypertensive drugs.  Details Animal research suggests that andrographis has hypotensive effects (2755,2760).

CELECOXIB (Celebrex) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and time to peak concentration of celecoxib. The clinical significance of these changes is unclear.  Details Animal research suggests that andrographis extract taken orally increases the maximum concentration and time to peak concentration of celecoxib but does not appear to impact the area under the curve (112916).

ETORICOXIB (Arcoxia) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might decrease the absorption of etoricoxib, although the clinical significance is unclear.  Details Animal research shows that andrographis extract, or the constituent andrographolide, taken orally with etoricoxib decreases the bioavailability of etoricoxib. However, this reduced bioavailability is not correlated with a reduction in the anti-inflammatory effects of etoricoxib in arthritic mice models (91837). The clinical significance of this interaction is unclear.

GLIPIZIDE (Glucotrol) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis extract might increase the maximum concentration and area under the curve of glipizide; however, opposite effects are seen with the constituent, andrographolide. The clinical significance of this interaction is unclear.  Details Animal research suggests that andrographis extract taken orally with glipizide in diabetes-induced rats increases the maximum concentration and area under the curve of glipizide. However, the opposite effect is seen with the constituent, andrographolide, in which the maximum concentration and area under the curve are decreased when taken with glipizide (112917).

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, andrographis might interfere with the effects of immunosuppressive drugs.  Details Laboratory research suggests that andrographolide has immunostimulant activity (2766).

(Read more about ANDROGRAPHIS)

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, chanca piedra might increase the risk of bleeding when used concomitantly with anticoagulant/antiplatelet drugs.  Details In vitro research suggests that methyl brevifolincarboxylate, a constituent isolated from chanca piedra, can inhibit platelet aggregation (41234). This effect has not been reported in humans.

ANTIDIABETES DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, concomitant use with antidiabetes drugs might affect glucose control and increase the risk of hypoglycemia.  Details Animal research suggests that chanca piedra can have hypoglycemic effects (19,41226,41280,41305,41306,41307). However, a small clinical study in adults with diabetes shows that chanca piedra extract 25 grams orally daily for 1 week does not lower fasting or postprandial blood glucose levels (41186).

ANTIHYPERTENSIVE DRUGS Interaction Rating = Minor Be watchful with this combination. Severity = Moderate •  Occurrence = Unlikely •  Level of Evidence = D Theoretically, concomitant use of chanca piedra with antihypertensive drugs might have additive blood pressure lowering effects.  Details Animal research suggests that chanca piedra can decrease blood pressure (41245). However, this effect was not observed in most hypertensive patients treated with chanca piedra for 10 days (3928).

DIURETIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of chanca piedra with diuretics might increase diuresis.  Details Some preliminary clinical research in adults with hypertension shows that chanca piedra has diuretic properties (3928). However, higher quality research in adults with kidney stones shows taking chanca piedra does not increase urine volume when compared with placebo (41202). Until more is known, use cautiously in patients taking diuretic drugs.

LITHIUM Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, chanca piedra might reduce excretion and increase levels of lithium.  Details Some preliminary clinical research in adults with hypertension shows that chanca piedra has diuretic properties (3928). However, higher quality research in adults with kidney stones shows that taking chanca piedra does not increase urine volume when compared with placebo (41202). Until more is known, use cautiously in patients taking lithium. The dose of lithium might need to be decreased.

NOREPINEPHRINE (Levophed) Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, chanca piedra may reduce the effects of norepinephrine.  Details Animal research suggests that methyl brevifolincarboxylate, a constituent isolated from chanca piedra, can reverse blood vessel contraction caused by norepinephrine (41215).

(Read more about CHANCA PIEDRA)

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

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

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

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

(Read more about INDIAN GOOSEBERRY)

AMOXICILLIN (Amoxil, Trimox) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of amoxicillin.  Details Evidence from animal research shows that piperine, a constituent of Indian long pepper, increases the plasma levels of amoxicillin when taken concomitantly (29269).

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the risk of bleeding when taken with anticoagulant/antiplatelet drugs.  Details In vitro research shows that Indian long pepper extract inhibits platelet aggregation (101151).

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Animal research shows that piperine, a constituent of Indian long pepper, can reduce blood glucose levels (29225). Monitor blood glucose levels closely. Dose adjustments might be necessary.

CARBAMAZEPINE (Tegretol) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian long pepper might increase blood levels of carbamazepine.  Details A small pharmacokinetic study in patients taking carbamazepine 300 mg or 500 mg twice daily shows that a single 20 mg dose of purified piperine, which is a constituent of Indian long pepper, increases carbamazepine levels. Piperine may increase absorption by increasing blood flow to the GI tract, increasing the surface area of the small intestine, or by cytochrome P450 3A4 (CYP3A4) inhibition in the gut wall. Absorption was significantly increased by 7-10 mcg/mL/hour. The time to eliminate carbamazepine was also increased by 4-8 hours. Although carbamazepine levels were increased, this did not appear to increase side effects (16833).

CEFOTAXIME (Claforan) Interaction Rating = Minor Be watchful with this combination. Severity = Mild •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of cefotaxime.  Details Animal research shows that piperine, a constituent of Indian long pepper, increases the plasma levels of cefotaxime when taken concomitantly (29269).

CYCLOSPORINE (Neoral, Sandimmune) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of cyclosporine.  Details In vitro research shows that piperine, a constituent of Indian long pepper, increases the bioavailability of cyclosporine (29282).

CYTOCHROME P450 1A1 (CYP1A1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of CYP1A1 substrates.  Details In vitro research shows that piperine, a constituent of Indian long pepper, inhibits CYP1A1 (29213).

CYTOCHROME P450 2B1 (CYP2B1) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of CYP2B1 substrates.  Details In vitro research shows that piperine, a constituent of Indian long pepper, inhibits CYP2B1 (29332).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the effects and adverse effects of CYP3A4 substrates.  Details In vitro research shows that piperine, a constituent of Indian long pepper, inhibits CYP3A4 (14375).

NEVIRAPINE (Viramune) Interaction Rating = Moderate Be cautious with this combination. Severity = Mild •  Occurrence = Probable •  Level of Evidence = B Theoretically, Indian long pepper might increase blood levels of nevirapine.  Details A small pharmacokinetic study shows that piperine, a constituent of Indian long pepper, increases the plasma concentration and systemic exposure of nevirapine. However, no adverse effects were associated with the elevated plasma levels of nevirapine (29209).

P-GLYCOPROTEIN SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase levels of P-glycoprotein substrates.  Details In vitro research shows that piperine, a constituent of Indian long pepper, can inhibit P-glycoprotein (14375,29281).

PENTOBARBITAL (Nembutal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase the sedative effects of pentobarbital.  Details Animal research shows that piperine, a constituent of Indian long pepper, can increase pentobarbitone-induced sleeping time (29214).

PHENYTOIN (Dilantin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian long pepper might increase blood levels of phenytoin.  Details A small pharmacokinetic study shows that piperine, a constituent of Indian long pepper, increases phenytoin serum levels and slows its elimination (537).

PROPRANOLOL (Inderal) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Theoretically, Indian long pepper might increase blood levels of propranolol.  Details A small pharmacokinetic study shows that piperine, a constituent of Indian long pepper, accelerates absorption and increases serum concentrations of propranolol (538).

RIFAMPIN (Rifadin) Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = D Theoretically, Indian long pepper might increase blood levels of rifampin.  Details Piperine, a constituent of Indian long pepper, seems to increase absorption and serum levels of rifampin (14375,29284).

THEOPHYLLINE Interaction Rating = Moderate Be cautious with this combination. Severity = High •  Occurrence = Possible •  Level of Evidence = B Indian long pepper might increase blood levels of theophylline.  Details A small pharmacokinetic study shows that piperine, a constituent of Indian long pepper, increases serum concentrations and slows elimination of theophylline (538).

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(Read more about MADDER)

ANTICHOLINERGIC DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D In vitro, purple nut sedge dose-dependently inhibits acetylcholinesterase (AChE) (27563). Theoretically, concurrent use of anticholinergic drugs and purple nut sedge might decrease the effectiveness of purple nut sedge or the anticholinergic agent.  Details Some anticholinergic drugs include atropine, benztropine (Cogentin), biperiden (Akineton), procyclidine (Kemadrin), and trihexyphenidyl (Artane).

ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D In vitro, purple nut sedge inhibits platelet aggregation (27551). Theoretically, purple nut sedge might increase the risk of bleeding when used with antiplatelet or anticoagulant drugs.  Details Some anticoagulant or antiplatelet drugs include aspirin, clopidogrel (Plavix), dalteparin (Fragmin), enoxaparin (Lovenox), heparin, ticlopidine (Ticlid), warfarin (Coumadin), and others.

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Evidence from animal research suggests that purple nut sedge can reduce blood glucose levels (27554). Theoretically, purple nut sedge 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 In vitro, purple nut sedge dose-dependently inhibits acetylcholinesterase (AChE) (27563). Theoretically, concurrent use of purple nut sedge with cholinergic drugs might have additive effects 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).

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ANTICOAGULANT/ANTIPLATELET DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, concomitant use of Terminalia arjuna with anticoagulant or antiplatelet drugs may increase the risk of bleeding in some patients.  Details In vitro, Terminalia arjuna bark extract inhibits platelet aggregation, decreases platelet activation, and shows antithrombotic properties (92831).

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2C9 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP2C9 enzymes and reduces CYP2C9 substrate metabolism (96729).

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP2D6 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP2D6 enzymes and reduces CYP2D6 substrate metabolism (96729).

CYTOCHROME P450 3A4 (CYP3A4) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, use of Terminalia arjuna may increase the levels and clinical effects of CYP3A4 substrates.  Details In vitro research shows that Terminalia arjuna extract inhibits CYP3A4 enzymes and reduces CYP3A4 substrate metabolism (96729).

(Read more about TERMINALIA ARJUNA)

ANTIDIABETES DRUGS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = A Theoretically, Tinospora cordifolia might increase the risk of hypoglycemia when taken with antidiabetes drugs.  Details Clinical research in adults with type 2 diabetes shows that Tinospora cordifolia can reduce fasting blood glucose and glycated hemoglobin (111503). Additionally, animal research shows that Tinospora cordifolia has hypoglycemic effects (15079,15080,15082,15083,106847).

CYTOCHROME P450 1A2 (CYP1A2) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP1A2.  Details In vitro research shows that Tinospora cordifolia extract inhibits CYP1A2 at high concentrations (98225). However, this interaction has not been reported in humans.

CYTOCHROME P450 2C19 (CYP2C19) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2C19.  Details In vitro research shows that Tinospora cordifolia extract inhibits CYP2C19 at high concentrations (98225). However, this interaction has not been reported in humans.

CYTOCHROME P450 2C9 (CYP2C9) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2C9.  Details In vitro research shows that Tinospora cordifolia extract inhibits CYP2C9. Animal research shows that Tinospora cordifolia extract 400 mg/kg twice daily for 14 days reduces the clearance and increases plasma levels of glyburide, a CYP2C9 substrate (98225). However, this interaction has not been reported in humans.

CYTOCHROME P450 2D6 (CYP2D6) SUBSTRATES Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Tinospora cordifolia might increase levels of drugs metabolized by CYP2D6.  Details In vitro research shows that Tinospora cordifolia extract inhibits CYP2D6 at high concentrations (98225). However, this interaction has not been reported in humans.

IMMUNOSUPPRESSANTS Interaction Rating = Moderate Be cautious with this combination. Severity = Moderate •  Occurrence = Possible •  Level of Evidence = D Theoretically, Tinospora cordifolia might reduce the effectiveness of immunosuppressants.  Details In vitro and animal research shows that Tinospora cordifolia has immunostimulant effects (15081,15086,15089).

(Read more about TINOSPORA CORDIFOLIA)

General ...Orally, andrographis is generally well tolerated. Adverse effects are more likely when doses reach or exceed 5-10 mg/kg of andrographolide content and when treatment duration exceeds 14 days.
Most Common Adverse Effects:
Orally: Abdominal discomfort, altered taste, diarrhea, dizziness, fatigue, headache, nausea and vomiting, pruritus, rash, and urticaria.
Serious Adverse Effects (Rare):
Orally: Severe allergic reactions, including anaphylaxis.

Cardiovascular ...Orally, andrographis has been reported to cause vasculitis, edema, and increased sweating (12380,13016,91841).

Dermatologic ...Orally, andrographis has been frequently reported to cause maculopapular, erythematous rash, pruritus, and urticaria (31223,31222,31233,12380,31231,31220,13016,91838,91841,104821)(107783,112921). Andrographis consumption has also been reported to cause angioedema, exfoliative dermatitis, skin exfoliation, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, bullous eruption, fixed eruption, stomatitis, allergic purpura, flushing, and swelling (91841).
Parenterally, there have been reports of maculopapular rash, urticaria, pruritus, and flushing with the use of andrographolide derivative injections; about one-third of patients experienced skin or subcutaneous reactions (112921).

Gastrointestinal ...Orally, andrographis has been reported to cause nausea, vomiting, diarrhea, dyspepsia, flatulence, altered or metallic taste, and abdominal discomfort (6767,31213,2748,13016,31220,31222,91841,104821,107783,112921). Andrographis intake has also been reported to cause epigastric pain, ulcerative stomatitis, melena, dry mouth, and dry lips (31213,10795,13016,91841).
Parenterally, there have been reports of diarrhea, nausea, vomiting, and abdominal discomfort with the use of andrographolide derivative injections; over 40% of patients experienced gastrointestinal events (112921).

Genitourinary ...Orally, there is one case report of increased urinary frequency associated with andrographis use (91841)

Hematologic ...Orally, there is one case report of epistaxis (nosebleed) associated with andrographis use (31222).

Hepatic ...Orally, there is one case report of hepatitis associated with andrographis use (91841).

Immunologic ...Orally, andrographis has been reported to cause anaphylactic shock in 2 cases with determined causality, and 7 cases with probable causality. Anaphylactic shock developed in 5 minutes to one day after oral intake, and included symptoms such as hypotension, chest pain, urticaria, angioedema, wheezing, and tachycardia (91841). Additionally, andrographis intake has been associated with cases of eosinophilia and fever (91841,107783). High doses of the andrographolide constituent (5-10 mg/kg daily) have been associated with two cases of lymphadenopathy and three cases of lymph node pain (6767).
Parenterally, there have been 97 cases reporting severe or life-threatening anaphylaxis after andrographolide derivative injections, 3 of which resulted in death (112921).

Musculoskeletal ...Orally, andrographis has been associated with case reports of pain, muscle weakness, cramps, and paralysis (31220,91841,107783).

Neurologic/CNS ...Orally, andrographis has been reported to cause headache, fatigue, anorexia, somnolence, insomnia, lethargy, malaise, and drowsiness (2748,5784,6767,10795,12380,13016,31220,31213,31222,91841,107783). Headache and fatigue occurred more often with high doses of the andrographolide constituent (5-10 mg/kg daily) in one clinical trial (6767).

Pulmonary/Respiratory ...Orally, andrographis has been reported to cause dyspnea, coughing, bronchospasm, increased sputum, and nasal congestion (10795,13016,31213,91841,107783).

(Read more about ANDROGRAPHIS)

General ...Orally, chanca piedra seems to be well tolerated. However, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Abdominal pain, nausea, vomiting.

Gastrointestinal ...Orally, use of chanca piedra can cause abdominal pain, nausea, and vomiting (99849,107946).

Ocular/Otic ...Orally, chanca piedra was associated with cases of visual impairment in one clinical trial (107946).

Other ...Orally, chanca piedra was associated with cases of fatigue in one clinical trial (107946).

(Read more about CHANCA PIEDRA)

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).

(Read more about INDIAN GOOSEBERRY)

General ...Orally, Indian long pepper is well tolerated when used in food (101151). No adverse effects have been reported when Indian long pepper is used as medicine. However, a thorough evaluation of safety outcomes has not been conducted.

(Read more about INDIAN LONG PEPPER)

General ...There is currently a limited amount of information available about the adverse effects of madder. Orally, madder can cause red colored urine, saliva, and perspiration (2). There is some concern that madder can stain contact lenses. Advise patients to be cautious (6002).
Topically, contact dermatitis has been reported while handling madder (20044).

Dermatologic ...Orally, madder can cause red-colored perspiration (2).

Gastrointestinal ...Orally, madder can cause red-colored saliva (2).

Genitourinary ...Orally, madder can cause red-colored urine (2).

Immunologic ...A case of contact dermatitis has been reported in a woman who handled madder while working in the garden (20044).

Ocular/Otic ...There is some concern that madder can stain contact lenses (6002).

(Read more about MADDER)

General ...There is currently a limited amount of information available about the adverse effects of purple nut sedge. Orally, purple nut sedge tuber seems to be generally well tolerated. In clinical research, purple nut sedge tuber 450 mg taken orally daily as a part of a combination product for 8 weeks did not cause adverse effects (89900). Topically, purple nut sedge essential oil seems to be well-tolerated, except for a complaint of bad odor (99457).

(Read more about PURPLE NUT SEDGE)

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.

(Read more about TERMINALIA ARJUNA)

General ...Orally, Tinospora cordifolia seems to be well tolerated. Topically, a thorough evaluation of safety outcomes has not been conducted.
Most Common Adverse Effects:
Orally: Headache and nasal pain.
Topically: Burning, erythema, and pruritus.
Serious Adverse Effects (Rare):
Orally: Liver injury has been reported.

Dermatologic ...Topically, Tinospora cordifolia has been reported to cause pruritus, erythema, and burning (92220).

Hepatic ...Orally, liver injury is reported after consumption of Tinospora cordifolia. In 2 case series, autoimmune hepatitis, acute hepatitis, worsening of chronic liver disease, or acute liver failure is reported in 49 patients after consuming various forms and doses of Tinospora cordifolia alone or in combination with other ingredients for a median of 42-90 days. Of these patients, 2 required a liver transplant and 4 died (110533,110534).
Liver injury is also reported in patients taking combination supplements containing Tinospora cordifolia. One case reports a 50-year-old female who presented with a 2-week history of constant right upper quadrant abdominal pain, nausea, loss of appetite, and fatigue, along with severely elevated alanine transaminase (ALT) and aspartate aminotransferase (AST), after taking a specific combination product containing Tinospora cordifolia 900 mg, stinging nettle 600 mg, and quercetin 600 mg (HistaEze) daily for 4 to 5 weeks (112404). Another case reports a 54-year-old female who developed acute hepatitis with elevated ALT, AST, alkaline phosphatase, gamma-glutamyl transferase, and bilirubin after consuming a multi-ingredient product containing approximately 1900 mg of Tinospora cordifolia and 11 other Ayurvedic herbals daily for 2.5 months (112405). In both cases, liver function returned to normal within 3 months of discontinuing the supplement (112404,112405). It is unclear whether the liver injury in these cases is due to Tinospora cordifolia, other ingredients, or the combination.

Neurologic/CNS ...Orally, Tinospora cordifolia has been reported to cause headache in a clinical trial (15085).

Pulmonary/Respiratory ...Orally, Tinospora cordifolia extract has been reported to cause nasal pain in a clinical trial (15085).

(Read more about TINOSPORA CORDIFOLIA)