Journal Article

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

Yi, Dan-hui, Xie, Yan-ming, Shen, Jian-wu, Zhang, Chun-he, Wang, Zhi-fei, Gao, Zhan, Gao, Wen-xi, Zeng, Wen-tong, Deng, Yue-yi, Lyu, Jian, Xiang, Song-tao, Wang, Lian-xin

2019

Overview

Background Acute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed with UTI each year worldwide. The high recurrence rate of lower UTI is a common problem of clinical treatment. The misuse of antibiotics has led to the emergence of a number of resistant bacterial strains. Thus, traditional Chinese medicine is considered as an alternative option for treating acute uncomplicated lower UTI. Thus, this study aims to evaluate the efficacy and safety of Sanjin tablets (SJT) for the treatment of acute uncomplicated lower UTI, explore whether SJT can reduce or substitute the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI. Methods/design In this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo; the control group 1 receives LT plus SJT placebo; and the control group 2 receives SJT plus LT on the first five days, SJT plus LT placebo on the last two days. Each group will be treated for seven days and followed-up 1–2 times. The primary outcome measures of effective rate and recurrence rate are symptoms. Secondary outcome measures of effective rate and recurrence rate are the urine leukocytes, bacteriology examination, and safety assessment. Outcomes will be assessed at baseline and after treatment. Discussion This study protocol will provide the research data of efficacy and safety of SJT for the treatment of acute uncomplicated lower UTI. The first aim is to determine whether Sanjin tablets can reduce the use of antibiotics; the second aim is to determine whether Sanjin tablets can substitute the use of antibiotics. The recurrence rate will be assessed after cured to determine whether SJT can reduce the recurrence rate. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment. Trial registration ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Acute uncomplicated UTI / Administration, Oral / Adult / Analysis / Anti-Bacterial Agents - administration & dosage / Anti-Bacterial Agents - adverse effects / Antibiotics / Asian medicine / Bacterial infections / Biomedicine / China / Clinical trials / Double-Blind Method / Double-blind studies / Drug therapy / Drugs / Drugs, Chinese Herbal - administration & dosage / Drugs, Chinese Herbal - adverse effects / Dysuria / Female / Health Sciences / Hospitals / Humans / Infection / Levofloxacin - administration & dosage / Levofloxacin - adverse effects / Lower Urinary Tract Symptoms - diagnosis / Lower Urinary Tract Symptoms - drug therapy / Lower Urinary Tract Symptoms - microbiology / Male / Medical diagnosis / Medical malpractice / Medical research / Medicine / Medicine & Public Health / Middle Aged / Multicenter Studies as Topic / Patients / Randomized controlled trial / Randomized Controlled Trials as Topic / Risk factors / Sanjin tablets / Statistics for Life Sciences / Study Protocol / Syndrome of dampness-heat in the lower jiao / Tablets / Time Factors / Traditional Chinese medicine / Treatment Outcome / Urinary tract diseases / Urinary tract infections / Urinary Tract Infections - diagnosis / Urinary Tract Infections - drug therapy / Urinary Tract Infections - microbiology / Urogenital system / Young Adult