Back to resultsClinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection
Primary Purpose
Urinary Tract Infection Lower Acute
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Sanjin tablets
Sanjin tablets simulants
Levofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Urinary Tract Infection Lower Acute focused on measuring Sanjin tablets, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
Sanjin tablets group
Levofloxacin group
Sanjin tablets+ Levofloxacin group
Arm Description
Sanjin tablets+ levofloxacin simulants
Sanjin tablets simulants +levofloxacin
Sanjin tablets+ levofloxacin
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT03658291
First Posted
July 24, 2018
Last Updated
November 22, 2018
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences, Shanghai University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03658291
Brief Title
Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
June 30, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Xiyuan Hospital of China Academy of Chinese Medical Sciences, Shanghai University of Traditional Chinese Medicine, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hubei Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Yunnan Provinical Hospital of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infection Lower Acute
Keywords
Sanjin tablets, efficacy and safety, recurrence rate, randomized, double blind, parallel control, multi-center clinical study
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sanjin tablets group
Arm Type
Experimental
Arm Description
Sanjin tablets+ levofloxacin simulants
Arm Title
Levofloxacin group
Arm Type
Placebo Comparator
Arm Description
Sanjin tablets simulants +levofloxacin
Arm Title
Sanjin tablets+ Levofloxacin group
Arm Type
Active Comparator
Arm Description
Sanjin tablets+ levofloxacin
Intervention Type
Drug
Intervention Name(s)
Sanjin tablets
Other Intervention Name(s)
levofloxacin simulants
Intervention Description
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
Intervention Type
Drug
Intervention Name(s)
Sanjin tablets simulants
Other Intervention Name(s)
Levofloxacin
Intervention Description
levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin
Other Intervention Name(s)
Sanjin tablets
Intervention Description
Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.
Primary Outcome Measure Information:
Title
The lower urinary tract infection symptoms of 252 participants will be assessed
Description
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
Secondary Outcome Measure Information:
Title
The urine leukocyte of 252 participants will be assessed
Description
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
Title
The bacteriological examination of 252 participants
Description
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
Title
The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms
Description
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
Title
The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte
Description
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
Title
The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination
Description
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.
Time Frame
28 days after the end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yanming Xie, BA
Phone
86-13911112416
Email
ktzu2018@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lianxin Wang, Doctor
Phone
86-13521781839
Email
wlxing@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanming Xie, BA
Organizational Affiliation
Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31324199
Citation
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.
Results Reference
derived
Learn more about this trial
Clinical Study of Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection
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