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A prospective, randomized, controlled study to evaluate the efficacy and tolerability of Ayurvedic formulation “varuna and banana stem” in the management of urinary stones

J Altern Complement Med. 2008 Dec;14(10):1287-90. doi: 10.1089/acm.2008.0189.

Patankar S1, Dobhada S, Bhansali M, Khaladkar S, Modi J.

Abstract

BACKGROUND:

Medical management of urinary calculus disease is a challenge for modern science. In the present trial Ayurvedic drug “Herbmed,” which is made up of varuna (Crataeva nurvala) and banana stem (Musa paradisiaca) was assessed to see reduction and/or expulsion of urinary calculi and also to assess the role of these drugs to reduce pain during expulsion.

MATERIALS AND METHODS:

In this prospective randomized, double-blind, placebo control trial, total 77 patients with calculi more than 5 mm were included. All patients were evaluated either by X-ray KUB or USG KUB for 3 months. All patients were divided into two groups: group A included patients with calculi 5-10 mm (n = 31) and group B with calculi > 10 mm (n = 30) with either active treatment or placebo in both the groups. All patients were asked to keep a record of number of pain episodes, while severity of pain was measured on a visual analogue scale (VAS).

RESULTS:

In group A, there was 33.04% reduction in the size of calculi in the active arm while there was a 5.13% increase in the same group in the placebo arm (p = 0.017). In the other group B, there was an 11.25% reduction in the active arm and a 1.41% reduction in the same group with placebo. In the active arm there was statistically significant lower VAS as compared to the placebo arm in the form of the highest VAS (p = 0.008), average VAS (p = 0.001) and VAS at the first episode of pain (p < 0.0001).

CONCLUSIONS:

Our preliminary experience suggests that the Ayurvedic formulation “varuna and banana stem” has promise for the management of upper urinary-tract calculi, especially renal calculi. It helps to dissolve renal calculi and facilitate their passage. In addition, it also helps in reduction of pain due to renal/ureteric calculus disease. A larger phase III study with a longer follow-up is required.

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*In vitro tests show that patented formula inhibits the rate of calcium oxalate crystal growth by 99%. Kidney C.O.P.® Patent: Compositions and methods to inhibit kidney stone growth.

**These statements have not been evaluated by the Food & Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

***Kidney C.O.P.® patented formulation contains clinically researched ingredients. Each active ingredient in Kidney C.O.P. (or a combination of the ingredients) have been clinically tested and shown, to varying degrees of potential, to inhibit the rate of calcium oxalate crystal growth.

****Many of Kidney C.O.P.’s active ingredients (or combination of) have been tested in clinical studies & have shown to have an effect inhibiting calcium oxalate crystal growth. Many of these clinical studies are found in the five patents: 9,233,135; 9,492,491; 9,623,006; 9,789,152; 10,471,115 – pgs 1 – 3 of each patent.

Caution: If you are pregnant, nursing, taking any medications or planning any medical procedure, consult your doctor before use. Discontinue use and consult your doctor if any adverse reactions occur.

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