Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Study Overview
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Brief Summary
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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.

Detailed Description
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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 thatAcupuncture effect is based on meridians, and gathering of meridian Qi is the key point.

Official Title
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Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Other: acupuncture
* Drug: Itopride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>specific acupoints of Stomach meridians | Other: acupuncture<br>* Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.<br>|
| Experimental: group 2<br>Non-specific acupoints of Stomach meridians | Other: acupuncture<br>* Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.<br>|
| Experimental: group 3<br>alarm and transport points | Other: acupuncture<br>* Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.<br>|
| Experimental: group 4<br>acupoints of the other meridian | Other: acupuncture<br>* Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.<br>|
| Sham Comparator: group 5<br>non-acupoints | Other: acupuncture<br>* Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.<br>|
| Active Comparator: group 6<br>Itopride | Drug: Itopride<br>* Each pill weighs 50mg, once a pill, three times a day. The pills are taken half an hour before meals, and be taken 4 weeks continuously.<br>* Other names: Itopride Hydrochloride Tablets;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nepean Dyspepsia Index |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms Index of Dyspepsia |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, meridian, acupoint