Acupuncture for Functional Dyspepsia: a Functional Magnetic Resonance Imaging (fMRI) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Nepean Dyspepsia Index (NDI)
研究概览
简要总结
He-Mu-point combination（ST36 and CV12） is one of the most commonly used acupoints combination with synergistic effect for functional dyspepsia(FD). The investigators design the trial to identify the efficacy and explore the central integrated mechanism of puncturing at He-Mu-point combination on FD with functional magnetic resonance imaging (fMRI).
详细描述
105 participants with functional dyspepsia will be allocated into three groups: Low-He point group, Mu point group and He-Mu-point combination group.Every participant will receive 20 sessions of manual acupuncture treatment during 4 weeks. Clinical evaluations will be assessed three times, as measured after randomization, 10 and 20 sessions of treatment.The fMRI scans will be conducted twice, after randomization and treatment completion.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •right handed，age between 18 and 45 years old, college degree or above;
- •match the Rome III criteria on FD;
- •no local organic disease by gastroscope examination;
- •before entering the study, without taking any prokinetic agents at least 15days and participating in other clinical study;
- •signing an informed consent in writing by the participant or the immediate family member.
排除标准
- •consciousness, cannot express subjective symptoms and psychiatric participants;
- •participants with advanced cancer or other serious wasting diseases, easy to be infected and bleeding;
- •complicating with severe cardiovascular, hepatic,nephritic,digestive, hematopoietic system diseases;
- •impregnate or lactation female;
- •severe depression and anxiety symptoms;
- •female with serious dysmenorrhea;
- •obvious headache, migraine, history of head injury.
研究组 & 干预措施
Low-He point(ST36)
Zusanli (ST36, the Low-He point of stomach) is the most important point for gastrointestinal disorder, including functional dyspepsia. Everyone in the group will be punctured at unilateral Zusanli.
干预措施: acupuncture (Other)
Mu point(CV12)
Zhongwan (CV12, the Mu point of stomach) is also good at regulating gastric function. Everyone in the group will be punctured at Zhongwan.
干预措施: acupuncture (Other)
He-Mu-point combination(ST36 and CV12)
In traditional Chinese acupuncture theory，synergistic effect can be produced by acupoints combination and the He-Mu-point combination is a classical acupoints combination formula for gastrointestinal diseases. Everyone in the group will be punctured at unilateral Zusanli and Zhongwan.
干预措施: acupuncture (Other)
结局指标
主要结局
Nepean Dyspepsia Index (NDI)
时间窗: 4 weeks after allocation
次要结局
- Self-Rating Anxiety Scale(0 day,2, 4weeks after allocation)
- Self-Rating Depression Scale(0 day,2, 4weeks after allocation)
- Leeds dyspepsia questionnaire(0 day,4 weeks after allocation)
- brain MRI data(0 day,4weeks after allocation)
- The incidence of adverse events during the 4 weeks(4weeks after allocation)