Clinical trial NCT03658291: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infection Lower Acute
Keywords: Sanjin tablets
efficacy and safety
recurrence rate
randomized
double blind
parallel control
multi-center clinical study
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
name: Shanghai University of Traditional Chinese Medicine
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hubei Hospital of Traditional Chinese Medicine
name: Chengdu University of Traditional Chinese Medicine
name: Yunnan Provinical Hospital of Traditional Chinese Medicine
First posted: 2018-09-05
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The lower urinary tract infection symptoms of 252 participants will be assessed
timeFrame: After 7 days of medication
Secondary outcomes:
measure: The urine leukocyte of 252 participants will be assessed
timeFrame: After 7 days of medication
measure: The bacteriological examination of 252 participants
timeFrame: After 7 days of medication
measure: The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms
timeFrame: 28 days after the end of treatment
measure: The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte
timeFrame: 28 days after the end of treatment
measure: The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination
timeFrame: 28 days after the end of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences
name: Yanming Xie, BA
role: PRINCIPAL_INVESTIGATOR
References:
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.