Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, People's Republic of China.
XiYuan Hospital, China Academy of Chinese Medical Sciences, Beijing, 100091, People's Republic of China.
Trials. 2019 Jul 19;20(1):446. doi: 10.1186/s13063-019-3539-5.
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.
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.
ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.
急性单纯性下尿路感染（UTI）是最常见的细菌性感染之一。患者通常表现为尿痛、尿急、尿频和耻骨上疼痛或压痛。全球每年约有 1.5 亿人被诊断患有 UTI。下尿路感染的高复发率是临床治疗中的一个常见问题。抗生素的滥用导致了许多耐药菌的出现。因此，中药被认为是治疗急性单纯性下尿路感染的一种替代选择。因此，本研究旨在评估三金片（SJT）治疗急性单纯性下尿路感染的疗效和安全性，探讨 SJT 是否能减少或替代抗生素的使用，并降低急性单纯性下尿路感染的复发率。
方法/设计：本研究将建立一项随机、双盲、双模拟、阳性药物对照、多中心临床研究。将 252 例急性单纯性下尿路感染（下焦湿热证）患者按 1:1:1 的比例随机分为三组：实验组、对照组 1 和对照组 2。实验组给予三金片加左氧氟沙星片（LT）安慰剂；对照组 1 给予 LT 加 SJT 安慰剂；对照组 2 在前 5 天给予 SJT 加 LT，后 2 天给予 SJT 加 LT 安慰剂。每组治疗 7 天，并随访 1-2 次。主要疗效指标为症状有效率和复发率，次要疗效指标为尿白细胞、细菌学检查和安全性评价。在基线和治疗后评估结果。
本研究方案将提供三金片治疗急性单纯性下尿路感染的疗效和安全性研究数据。第一个目的是确定三金片是否能减少抗生素的使用；第二个目的是确定三金片是否能替代抗生素的使用。治愈后评估复发率，以确定三金片是否能降低复发率。本研究的结果将改善药物的合理使用，特别是抗生素的合理应用。它还将从实验室指标和不良事件中进行安全性评估，为临床治疗提供可靠的证据。
ClinicalTrials.gov，NCT03658291。注册于 2018 年 9 月 4 日。
