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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.
- Source :
-
Trials [Trials] 2019 Jul 19; Vol. 20 (1), pp. 446. Date of Electronic Publication: 2019 Jul 19. - Publication Year :
- 2019
-
Abstract
- 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.<br />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.<br />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.<br />Trial Registration: ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.
- Subjects :
- Administration, Oral
Adult
Anti-Bacterial Agents adverse effects
China
Double-Blind Method
Drugs, Chinese Herbal adverse effects
Female
Humans
Levofloxacin adverse effects
Lower Urinary Tract Symptoms diagnosis
Lower Urinary Tract Symptoms microbiology
Male
Middle Aged
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Tablets
Time Factors
Treatment Outcome
Urinary Tract Infections diagnosis
Urinary Tract Infections microbiology
Young Adult
Anti-Bacterial Agents administration & dosage
Drugs, Chinese Herbal administration & dosage
Levofloxacin administration & dosage
Lower Urinary Tract Symptoms drug therapy
Urinary Tract Infections drug therapy
Subjects
Details
- Language :
- English
- ISSN :
- 1745-6215
- Volume :
- 20
- Issue :
- 1
- Database :
- MEDLINE
- Journal :
- Trials
- Publication Type :
- Academic Journal
- Accession number :
- 31324199
- Full Text :
- https://doi.org/10.1186/s13063-019-3539-5