Evaluation of safety and efficacy of Stondab tablets in the management of Urinary Calculi: An open label, randomized, multi-center, prospective, comparative clinical study

Background: The pathogenesis and treatment of Ashmari (Urolithiasis) are well explained in Ayurveda texts. While various herbal remedies are used for the medical management of Urolithiasis, very few have been studied clinically for safety and efficacy. Objective: To evaluate the safety and efficacy of Stondab tablet in reducing the size and expelling of urinary calculi and in relieving the symptoms of calculi. Materials and Methods: The study was conducted in a Randomized, Active Controlled, Open Labelled, Multi-centric design with 108 subjects completing the study. Subjects were given either test product or comparator as per randomization, two tablets, thrice daily for the period of 90 days to be taken with water. Subjects were followed up every 15 days for 90 days for clinical and laboratory assessment as planned. Results: Subjects in the Stondab group showed an expulsion rate of calculi (5-12 mm) of 49.23% and 66.66% (less than 5 mm) at the end of 90 days. There was a reduction in clinical symptoms like pain in the abdomen, burning micturition, hematuria, painful micturition, frequency of micturition, and the number of episodes of pain in the Stondab group and which was comparable with the comparator group. The study product was found to be safe and well-tolerated. Conclusion: It may be concluded that Stondab is safe and effective in the management of renal calculi. It also helped in the reduction of clinical symptoms of renal calculi as well as there is a clinically significant effect on new stone formation.