NCT00786214已完成不适用
Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Resolution of symptoms
研究概览
简要总结
Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.
排除标准
- •Subjects unable to give informed consent
- •Pregnant or breast-feeding females or women who get pregnant midway
- •Subjects who have received acupuncture treatment before
- •Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
- •Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
- •Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
- •Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
- •H. pylori eradication treatment within the past 12 months before study start
- •H. pylori positive patients
- •Patients with bleeding diathesis
- •Known or suspected hypersensitivity to acupuncture.
研究组 & 干预措施
Acupuncture
Experimental
Patients given acupuncture treatment
干预措施: Acupuncture (Other)
Sham acupuncture
Sham Comparator
Patients given sham acupuncture treatment
干预措施: Sham acupuncture (Other)
结局指标
主要结局
Resolution of symptoms
时间窗: 4 weeks
次要结局
- Health-related quality of life and hospital anxiety & depression scale(4 weeks)
研究者
Medicine
Professor & Senior Consultant Gastroenterologist, Ho Khek Yu
National University Hospital, Singapore
研究点 (1)
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