Evaluation of an Ayurvedic formulation (Cystone), in urolithiasis: A double blind, placebo-controlled study

Aim of the study: To evaluate the safety and efficacy of Ayurvedic formulation in patients with urolithiasis by assessing the symptomatic relief, reduction/expulsion of renal stones, urinary biochemical parameters. Materials and methods: In this study, 60 patients with renal calculi size between 5mm and 12 mm were included. Thirty patients received Ayurvedic formulation and remaining 30 received placebo orally in a dose of 2 tablets twice daily for 12 weeks. Patients were evaluated at 6 and 12 weeks for relief of clinical symptoms as well as urine and biochemical parameters. X-ray (KUB) and an ultrasound examination were carried out on entry, 6 weeks, 12 weeks of the study. Results: The Ayurvedic formulation helped in expulsion of stones in 18 patients (66.7%) {placebo 3 (10%)}. The average time for expulsion was 12.3 days (range 7-20) in patients treated with Ayurvedic formulation with a significant reduction in the calculi size, whereas there was no decrease in the size of the stone in patients treated with placebo. There were improvement in clinical symptoms and hematuria, frequency of urination, and tenderness in KUB area. Significant reduction in the number of urinary RBC and WBC was observed in patients on Ayurvedic formulation along with significant decrease in serum uric acid levels. Conclusions: This Ayurvedic formulation appears to be safe and beneficial in patients who have smaller renal stones. It increases the stone expulsion rate. (C) 2011 Elsevier GmbH. All rights reserved.