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

BACKGROUND Medical management of urinary calculus disease is a challange 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.