Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
研究概览
简要总结
The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).
详细描述
Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.
Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed as IBS according to the Rome III criteria;
- •Diarrhea was present for at least 75% of the time;
- •With a TCM differentiation as "liver stagnation and spleen defficiency"
- •Had a colonoscopy within a year to rule out other bowel diseases.
排除标准
- •Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
- •Had gastrointestinal surgery within a year;
- •Used durgs that affect gastrointestinal motility;
- •Had psychological disorder;
- •Serious disease in other system, which may bias the outcome measures.
研究组 & 干预措施
Tong-Xie-Yao-Fang
Tong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks.
干预措施: Tong-Xie-Yao-Fang (Drug)
Placebo
It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules.
干预措施: Placebo (Drug)
结局指标
主要结局
the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
时间窗: 4 weeks after initiation of treatment
次要结局
- An visual scale rating the degree of IBS-D symptoms(baseline(week 0), week 4, week 8, week 12)
- Stool frequency per week(baseline(week 0), week 4, week 8, week 12)
- Proportion of adverse events(week 4)