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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
252
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.
The lower urinary tract infection symptoms of 252 participants will be assessed
The symptoms mainly includes frequent urination,urgent urination,urinary pain, lower abdominal pain and pain in the kidney area.If these symptoms disappear after 7 days of medication,it indicates the subject is cured.
Time frame: After 7 days of medication
The urine leukocyte of 252 participants will be assessed
If the urine leukocyte return to normal value after 7 days of medication,it indicates the subject is cured.
Time frame: After 7 days of medication
The bacteriological examination of 252 participants
If the original infected part of the specimen did not regenerate the original infected pathogen after 7 days of medication,it indicates the subject is cured.
Time frame: After 7 days of medication
The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms
If the lower urinary tract infection symptoms of subjects who is cured appears again in the fourth week after end of medication,it indicates the subject has relapsed.
Time frame: 28 days after the end of treatment
The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte
If the urine leukocyte value of subjects who is cured rises again in the fourth week after end of medication,it indicates the subject has relapsed.
Time frame: 28 days after the end of treatment
The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination
If the urine culture of subjects who is cured indicates that the original urinary tract pathogen is positive again in the fourth week after end of medication,it indicates the subject has relapsed.
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Time frame: 28 days after the end of treatment