Phase III Study of Acupuncture for Patients With Functional Dyspepsia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The proportion of participants reporting complete absence of dyspeptic symptoms
研究概览
简要总结
Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia
Design:
- A single blind randomized controlled trial
- 200 participants will be included
- Two arms: acupuncture and sham acupuncture group
详细描述
Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.
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
- 是
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）
- •Include postprandial distress syndrome.
- •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.
结局指标
主要结局
The proportion of participants reporting complete absence of dyspeptic symptoms
时间窗: at 16 weeks after inclusion
次要结局
- validated Leeds Dyspepsia Questionnaire(4, 8, 16, 20, 24 weeks after inclusion)
- Nepean dyspepsia index(4, 8, 16, 20, 24 weeks after inclusion)
- adverse events in each group(4 weeks after inclusion)