Royal Break Stone Tea by Whole World Botanicals

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 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.

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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).

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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).

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