Acupuncture for Functional Bowel Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 449
- 试验地点
- 1
- 主要终点
- Average weekly stool frequency
研究概览
简要总结
This trial is to assess the effectiveness of three types of acupuncture for patients with functional diarrhea comparing to a positive drug control.
详细描述
Outcome measurements:
The frequency of bowel movement; The bristol stool scale; SF-36 evaluation
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as diarrhoea-predominant irritable bowel syndrome according to Rome III criteria;
- •Age between 18 and 65 years old;
- •Did not take any medicine for bowel symptoms and attend other clinical research;
- •Have inform consent signed.
排除标准
- •Diarrhea caused by diseases such as infection, etc.
- •Patients can't express himself clearly or with mental diseases;
- •Tumor and other infectious diseases;
- •With other serious diseases of Cardiovascular, liver, kidney, digestive or blood system; Pregnant women or planned to be pregnant.
研究组 & 干预措施
acupuncture group 1
Acupoints ST25 and BL25 will be used in the group. ST25 locate at the abdomen, while BL25 locate at the back.
干预措施: acupuncture (Other)
acupuncture group 2
Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
干预措施: acupuncture group2 (Other)
acupuncture group 3
All acupoints used in acupuncture group1 and acupuncture group2 will be used in this group.
干预措施: acupuncture group3 (Other)
Loperamide
Loperamide will be used as an active comparator to the acupuncture groups.
干预措施: Loperamide (Drug)
结局指标
主要结局
Average weekly stool frequency
时间窗: 4th week after inclusion
Average weekly stool frequency, change from baseline in 4 weeks
次要结局
- Assessment score of Bristol stool scale(4th and 8th week after inclusion)
- Assessment score of SF-36 scale(4th and 8th after inclusion)
- Number of patients with adverse events after treatment(4th week after inclusion)