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.

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.

[Yuleshu oral mixture combined with conventional therapy for chronic prostatitis].

OBJECTIVE: To evaluate the clinical effects of Yuleshu oral mixture combined with conventional therapy on chronic prostatitis. METHODS: Eighty-eight patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) were equally randomized to a control and an experimental group to receive conventional therapy (oral antibiotics, alpha blockers, proprietary Chinese medicine for activating blood circulation and massage of the prostate) and conventional therapy combined with Yuleshu oral mixture respectively. Before and after treatment, the severity of symptoms and sexual function of the patients were evaluated using NIH-CPSI and IIEF-5, their anxiety, depression and other emotional problems assessed with Hamilton Depression Rating Scale (HAMD) and Hamilton Anxiety Scale (HAMA), and the results subjected to statistical analysis. RESULTS: Both the experimental and control groups showed significant improvement in prostatitis symptoms and sexual function after treatment as compared with the baseline (P < 0.01), even more significant in the former than in the latter group, especially in pain symptoms (7.89 +/- 2.82 vs 10.41 +/- 2.55, P < 0.01). Before and after treatment, the HAMA and HAMD score had no significant difference in the control, but there was significant difference in the experimental group. The experimental group exhibited remarkably higher scores after than before treatment on HAMA (24.30 +/- 5.07 vs 13.80 +/- 3.62, P < 0.01) and HAMD (23.81 +/- 5.01 vs 16.23 +/- 5.93, P < 0.01), but not the control group (P > 0.05). CONCLUSION: Yuleshu oral mixture can effectively relieve anxiety, depression and other psychological problems in CP/CPPS patients, and improve their clinical symptoms as well. Therefore, it is an effective drug for chronic prostatitis.