Yong-li Zhan1, Xiu-ying Li, Sheng-xian Wu. 1. Department of Nephrology, Guang' anmen Hospital Affiliated to China Academy of Chinese Medical Sciences, Beijing. zhanyongli88@sina.com
Abstract
OBJECTIVE: To evaluate the safety and efficacy of Compound Shiwei Tablet (CST) in treating upper and lower urinary tract infection (UTI, pyretic stranguria of dampness-heat of the Lower-jiao type in 'TCM). METHODS: A multi-center, randomized, and opened clinical trial was conducted in the UTI patients with Sanjin Tablet (ST) as the parallel positive control medicine. The comprehensive efficacy, effect on TCM syndrome score, and change of urinary leukocyte count were observed, and the adverse reaction was recorded. RESULTS: In the 147 upper UTI cases and the 312 lower UTI cases after treatment, the comprehensive effect was higher and urinary leukocyte was less in the CST treated patients than in the ST treated patients (P < 0.05); but significant difference in the improvement of TCM symptoms was found between them only in the lower UTI cases ( P < 0.05); and no adverse reaction was observed during the treatment course. CONCLUSION:CST has definite therapeutic efficacy on UTI and is safe in clinical application.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of Compound Shiwei Tablet (CST) in treating upper and lower urinary tract infection (UTI, pyretic stranguria of dampness-heat of the Lower-jiao type in 'TCM). METHODS: A multi-center, randomized, and opened clinical trial was conducted in the UTI patients with Sanjin Tablet (ST) as the parallel positive control medicine. The comprehensive efficacy, effect on TCM syndrome score, and change of urinary leukocyte count were observed, and the adverse reaction was recorded. RESULTS: In the 147 upper UTI cases and the 312 lower UTI cases after treatment, the comprehensive effect was higher and urinary leukocyte was less in the CST treated patients than in the ST treated patients (P < 0.05); but significant difference in the improvement of TCM symptoms was found between them only in the lower UTI cases ( P < 0.05); and no adverse reaction was observed during the treatment course. CONCLUSION: CST has definite therapeutic efficacy on UTI and is safe in clinical application.
Authors: Andrew Flower; Kim Harman; George Lewith; Michael Moore; Felicity L Bishop; Beth Stuart; Nicholas Lampert Journal: Trials Date: 2016-07-27 Impact factor: 2.279