EVALUATION OF ANTIUROLITHIC HERBAL FORMULA FOR UROLITHIASIS: A RANDOMIZED OPEN-LABEL CLINICAL STUDY

Abstract

Objective: The objective of the study was to evaluate the safety and efficacy of antiurolithic herbal formula (AHF) compared with commercial polyherbal lithotriptic (CPL) agent in urolithiasis subjects. Materials and Method: The study was conducted with the design of purposive randomized open-label, end-blinded observation. The sample size and randomization were done by computer with generated statistical program. The total of subjects who met the inclusion and exclusion criteria was 200 patients. Every subject was given AHF or CPL according to their group and the intervention was carried out for 8 weeks. The study used the difference of stone’s size and number as parameter to observe the efficacy between two groups. While in terms of safety, this study used biochemical parameters of liver and kidney function. Results: A total of 191 adult patients with urolithiasis were enrolled. There were 97 and 94 subjects in AHF and CPL group, respectively. The study showed a significant size reduction of single’s and multiple’s stone in AHF group (p<0.05). The size reduction difference in AHF group is greater than in CPL group. The number of multiple stone’s subjects who treated AHF was significantly decreased. Whereas in CPL group, there was no significant size difference between pre and prost treatment. The biochemical parameters showed normal liver and renal function in both groups. Conclusion: This study result indicates that AHF is safe and effective in the treatment of urolithiasis.