Safety and efficacy of an herbal formulation in patients with renal calculi - A 28 week, randomized, double-blind, placebo-controlled, parallel group study

Autor: Suresh B. Patankar, A.M. Mujumdar, Fanthome Bernard, Phadke Supriya
Jazyk: angličtina
Rok vydání: 2020
Předmět:
Zdroj: Journal of Ayurveda and Integrative Medicine, Vol 11, Iss 1, Pp 62-67 (2020)
Druh dokumentu: article
ISSN: 0975-9476
DOI: 10.1016/j.jaim.2018.08.001
Popis: Background: Urolithiasis is a growing problem worldwide. Many a times, asymptomatic stones are kept under observation. Many herbal preparations are available for the same, but they lack proper scientific documentation. 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 trial conducted in a tertiary care hospital in Pune, India.Patients with asymptomatic renal calculi of 4–9 mm size were randomized (1:1, block randomization) to one of the group Subap Plus (treatment group) or placebo (placebo group). The study outcome included change 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, of which 65 patients completed the trial (treatment, n = 34; placebo, n = 31). The VAS score significantly decreased in the treatment group (6.9–1.8) than placebo group (7.2–6.8) (p
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