Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection

Sponsor

China Academy of Chinese Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT03658291

Collaborator

Xiyuan Hospital of China Academy of Chinese Medical Sciences (Other), Shanghai University of Traditional Chinese Medicine (Other), Guangdong Provincial Hospital of Traditional Chinese Medicine (Other), Hubei Hospital of Traditional Chinese Medicine (Other), Chengdu University of Traditional Chinese Medicine (Other), Yunnan Provinical Hospital of Traditional Chinese Medicine (Other)

252

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection Lower Acute	Drug: Sanjin tablets Drug: Sanjin tablets simulants Drug: Levofloxacin	Phase 4

Detailed 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

Study Type:

Interventional

Anticipated Enrollment :

252 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study

Anticipated Study Start Date :

Jan 1, 2019

Anticipated Primary Completion Date :

Jun 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sanjin tablets group Sanjin tablets+ levofloxacin simulants	Drug: Sanjin tablets Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days. Other Names: levofloxacin simulants
Placebo Comparator: Levofloxacin group Sanjin tablets simulants +levofloxacin	Drug: Sanjin tablets simulants levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days. Other Names: Levofloxacin
Active Comparator: Sanjin tablets+ Levofloxacin group Sanjin tablets+ levofloxacin	Drug: Levofloxacin Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days. Other Names: Sanjin tablets

Arm

Intervention/Treatment

Experimental: Sanjin tablets group

Sanjin tablets+ levofloxacin simulants

Drug: Sanjin tablets

Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.

Other Names:

levofloxacin simulants

Placebo Comparator: Levofloxacin group

Sanjin tablets simulants +levofloxacin

Drug: Sanjin tablets simulants

levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.

Other Names:

Levofloxacin

Active Comparator: Sanjin tablets+ Levofloxacin group

Sanjin tablets+ levofloxacin

Drug: Levofloxacin

Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.

Other Names:

Sanjin tablets

Outcome Measures

Primary Outcome Measures

The lower urinary tract infection symptoms of 252 participants will be assessed [After 7 days of medication]
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.

Secondary Outcome Measures

The urine leukocyte of 252 participants will be assessed [After 7 days of medication]
If the urine leukocyte return to normal value after 7 days of medication,it indicates the subject is cured.
The bacteriological examination of 252 participants [After 7 days of medication]
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.
The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms [28 days after the end of treatment]
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.
The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte [28 days after the end of treatment]
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.
The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination [28 days after the end of treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subjects aged 18 to 50 years of age.
Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
Urine retention in the screening period -1-0 days, bacterial culture results were sensitive to levofloxacin.(Urine retention for bacterial culture and clinical treatment at the same time)
The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
Did not receive antibiotic treatment within 48 hours Before being selected.
The inclusion of those who confirmed not pregnant
Those who agree to participate in this clinical trial and sign the informed consent, the process of informed consent meet the relevant provisions of the GCP.

Exclusion Criteria:

Those who are allergic to the test drug ingredients or quinolones.
In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
Diagnosed as complicated urinary tract infection.
Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
Combined with vaginitis symptoms, genital ulcers or gonorrhea.
Combined with severe cardiopulmonary disease, liver and kidney disease, advanced tumor, blood, central nervous system (such as the history of epilepsy) or other serious or progressive disease.
A patient who has a neurological or mental illness and cannot cooperate.
Infected persons who must use other antibacterial drugs in combination.
Pregnancy, lactating women or recent birth planners.
Those who have participated in other clinical trials within 3 months before being selected.