NCT02421627已完成不适用
Study on the Mechanism of Moxibustion Effect on Treating Diarrhea-predominant Irritable Bowel Syndrome
Shanghai Institute of Acupuncture, Moxibustion and Meridian3 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2015年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 3
- 主要终点
- Total efficacy (Adequate relief responder)
研究概览
简要总结
To observe the safety and efficacy of moxibustion on diarrhea-predominant irritable bowel syndrome and evaluation by Magnetic Resonance Imaging (MRI), Event related potential (ERP).
详细描述
- A randomized controlled trial
- Moxibustion treatment, sham control
- To observe the safety and efficacy of moxibustion treatment versus placebo control
- Evaluation by intestinal microbial structural and diversity changes using 16S rDNA sequencing
- Evaluation by structural MRI and resting state-functional MRI
- Evaluation by ERP
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 (Participant, 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
- 是
入选标准
- •Diarrhea-predominant IBS patients who met the Rome III diagnostic criteria;
- •Age 18-65 years old, male or female;
- •Volunteered for the trial, signed the informed consent
排除标准
- •Intestinal organic disease;
- •Constipation-predominant IBS;
- •Alternating diarrhea and constipation IBS;
- •Unstructured IBS;
- •At the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;
- •Combined liver, kidney, heart or mental disease patients;
- •Pregnant or lactating women.
结局指标
主要结局
Total efficacy (Adequate relief responder)
时间窗: Week 6
The ratio of the number of responders and the total number of participants in each group. Adequate relief responder is the participant who considered effective treatment in the self-assessment.
次要结局
- The proportion of responder to SSS(Week 6, 12, 18 and 24)
- Bristol stool form scale (BSS)(Week 6, 12, 18 and 24)
- Total efficacy (Adequate relief responder)(Week 12, 18 and 24)
- Symptom severity score (SSS)(Week 6, 12, 18 and 24)
- hospital anxiety and depression score (HADS)(Week 6)
- Quality of life questionnaire (IBS-QOL)(Week 6)
- Urgency of defecation(Week 6, 12, 18 and 24)
- Self-rating anxiety scale (SAS)(Week 6)
- Self-rating Depression Scale (SDS)(Week 6)
- Diarrhea frequency per day(Week 6, 12, 18 and 24)
- Safety evaluation (Number of participants with treatment-related adverse events as assessed by CTCAE v4.0)(Week 6, 12, 18 and 24)
研究者
研究点 (3)
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