ABSTRACT
Background: Urolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are keptunder observation. Many herbal preparations are available for the same, but they lack proper scientificdocumentation.Objective: To study the anti-urolithiatic effect of an herbal preparation, Subap Plus (IP) capsules in patients with asymptomatic renal calculi of size ranging from 4 to 9 mm.Material and methods: This was a prospective, randomized, double-blind, placebo-controlled clinical trialconducted in a tertiary care hospital in Pune, India.Patients with asymptomatic renal calculi of 4e9 mm size were randomized (1:1, block randomization) toone of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome includedchange in visual analog scale (VAS), change in the surface area and density of calculi and their expulsion.Statistical analysis was performed using student's t-test and Chi-square test.Results: A total of 120 patients were screened and 84 were enrolled who met the eligibility criteria, ofwhich 65 patients completed the trial (treatment, n ¼ 34; placebo, n ¼ 31). The VAS score significantlydecreased in the treatment group (6.9e1.8) than placebo group (7.2e6.8) (p < 0.001). The surface areaand density were decreased by 47.58% (p < 0.008) and 43.01% (p < 0.001), respectively, in the treatmentgroup than the placebo group. The expulsion of calculi was significantly higher in the treatment groupthan placebo group (20.59 vs. 3.23%, p < 0.03).Conclusion: Patients treated with herbal formulation showed better expulsion rate and reduction insurface area and density than the placebo group.© 2018 Transdisciplinary University, Bangalore and World Ayurveda Foundation. Publishing Services byElsevier B.V. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).