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

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

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.

Study Overview

• Status: Unknown
• Conditions: Urinary Tract Infection Lower Acute
• Intervention / Treatment: Drug: Sanjin tablets; Drug: Sanjin tablets simulants; Drug: Levofloxacin

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 Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yanming Xie, BA; Phone Number: 86-13911112416; Email: ktzu2018@163.com
• Study Contact Backup: Name: Lianxin Wang, Doctor; Phone Number: 86-13521781839; Email: wlxing@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	After 7 days of medication

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	28 days after the end of treatment

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Chengdu University of Traditional Chinese Medicine; Xiyuan Hospital of China Academy of Chinese Medical Sciences; Shanghai University of Traditional Chinese Medicine; Hubei Hospital of Traditional Chinese Medicine; Yunnan Provinical Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• Lyu J, Xie YM, Gao Z, Shen JW, Deng YY, Xiang ST, Gao WX, Zeng WT, Zhang CH, Yi DH, Wang LX, Wang ZF. Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial. Trials. 2019 Jul 19;20(1):446. doi: 10.1186/s13063-019-3539-5.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2019
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 24, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (Actual): September 5, 2018

Study Record Updates

• Last Update Posted (Actual): November 26, 2018
• Last Update Submitted That Met QC Criteria: November 22, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: efficacy and safety; randomized; double blind; Sanjin tablets; recurrence rate; parallel control; multi-center clinical study
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: Sanjin tablets

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No