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Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate.


Clinical Trial Description

In order to evaluating the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate and through research data to guide clinical, improving the rational use of drugs, especially the rational application of antibiotics. In this study, a randomized, double blind, parallel control of positive drugs, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 252 cases need to be registered at least. These cases will be divided into treatment group(Sanjin tablets+ levofloxacin simulants),control group 1(Sanjin tablets simulants +levofloxacin)and control group 2(Sanjin tablets+ levofloxacin). Each group will be treated for 7 days and followed up for 2 times. The efficacy indicators of this study were mainly from three dimensions: syndrome, laboratory routine examination and bacteriology examination. The symptom scores and cytokine changes of each group before and after treatment were observed. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03658291
Study type Interventional
Source China Academy of Chinese Medical Sciences
Contact Yanming Xie, BA
Phone 86-13911112416
Email ktzu2018@163.com
Status Not yet recruiting
Phase Phase 4
Start date January 1, 2019
Completion date December 31, 2019

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