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

Phase 4

• Conditions: Urinary Tract Infection Lower Acute
• Interventions: Drug: Sanjin tablets simulants; Drug: Sanjin tablets; Drug: Levofloxacin

• Registration Number: NCT03658291
• Lead Sponsor: China Academy of Chinese Medical Sciences

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.

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 Timeline

• Study First Submitted: 2018-07-24
• Study First Submitted QC: 2018-09-04
• Study First Posted: 2018-09-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-22
• Last Update Posted: 2018-11-26
• Study Start: 2019-01-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

1. Subjects aged 18 to 50 years of age.
2. Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
3. 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)
4. The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
5. Did not receive antibiotic treatment within 48 hours Before being selected.
6. The inclusion of those who confirmed not pregnant
7. 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

1. Those who are allergic to the test drug ingredients or quinolones.
2. In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
3. Diagnosed as complicated urinary tract infection.
4. Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
5. Combined with vaginitis symptoms, genital ulcers or gonorrhea.
6. 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.
7. A patient who has a neurological or mental illness and cannot cooperate.
8. Infected persons who must use other antibacterial drugs in combination.
9. Pregnancy, lactating women or recent birth planners.
10. Those who have participated in other clinical trials within 3 months before being selected.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin group	Sanjin tablets simulants	Sanjin tablets simulants +levofloxacin
Sanjin tablets group	Sanjin tablets	Sanjin tablets+ levofloxacin simulants
Sanjin tablets+ Levofloxacin group	Levofloxacin	Sanjin tablets+ levofloxacin

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 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 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.