A Randomized, Open label, Comparative Clinical Study to Evaluate the Efficacy and Safety of Cystone Forte Tablet in Urolithiasis

Abstract

The aim of the study was to evaluate the efficacy and safety of Cystone forte tablet in urolithiasis. A randomized, open-label, comparative clinical study was conducted in sixty-two subjects presenting with urolithiasis as diagnosed clinically with calculi measuring 5 to 12mm in size and subjects aged between 18-50 years of either sex. Sixty-two subjects were randomized into trial group and comparator group. Trial group subjects received Cystone forte tablet in the dose of 2 tablets twice daily for a period of 6 weeks while the comparator group received Tamsulosin tablet in the dose of 1 tablet once daily for a period of 6 weeks. The trial group subjects treated with Cystone forte tablets showed comparable results with the improvement of clinical parameters in urolithiasis and with the expulsion of kidney stones as compared to Tamsulosin group. The trial group receiving Cystone forte tablet was found to be effective and was beneficial in the management of urolithiasis. At the end of the study, mild occasional adverse events were reported in both the groups which were resolved. This clinical study demonstrates that, oral administration of Cystone forte tablets at the recommended dose is safe and effective in relieving the symptoms of urolithiasis.