Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 720
- 试验地点
- 1
- 主要终点
- Nepean Dyspepsia Index
研究概览
简要总结
The purpose of the study is to testify the efficacy of treating functional dyspepsia with acupuncture, and provide evidence for the hypothesis that "Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
详细描述
The purpose of the study is to testify whether acupuncture is effective for functional dyspepsia, through treating functional dyspepsia patient for a month, using different acupoints according to literatures of treating migraine with acupuncture, and using Itopride as controlled group, and try to provide clinical evidence for the hypothesis that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."
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
- Triple (Participant, 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
- •Consistent with the diagnostic criteria of functional dyspepsia.
- •Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
- •Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
- •Informed consent is signed by a subject or his lineal relation.
排除标准
- •Patients with any contraindications of Itopride.
- •Patients who are unconscious, psychotic.
- •Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
- •With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
- •Pregnant women or women in lactation.
研究组 & 干预措施
group 1
specific acupoints of Stomach meridians
干预措施: acupuncture (Other)
group 2
Non-specific acupoints of Stomach meridians
干预措施: acupuncture (Other)
group 3
alarm and transport points
干预措施: acupuncture (Other)
group 4
acupoints of the other meridian
干预措施: acupuncture (Other)
group 5
non-acupoints
干预措施: acupuncture (Other)
group 6
Itopride
干预措施: Itopride (Drug)
结局指标
主要结局
Nepean Dyspepsia Index
时间窗: 4 weeks
次要结局
- Symptoms Index of Dyspepsia(4 weeks)