Acupuncture for Patients With Function Dyspepsia

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Phase III Study of Acupuncture for Patients With Functional Dyspepsia

Conditions
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Functional Dyspepsia, Postprandial Distress Syndrome

Intervention / Treatment
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* Other: acupuncture
* Other: sham acupuncture


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） 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. 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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Accepts Healthy Volunteers

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: acupuncture group<br>use traditional acupuncture to treat functional dyspepsia | Other: acupuncture<br>* In this group, acupuncture is given according to traditional acupuncture theories.<br>* Other names: use hwato acupuncture needles;|
| Sham Comparator: sham acupuncture group<br>use penetrating sham acupuncture to manage functional dyspepsia | Other: sham acupuncture<br>* Sham acupuncture points will be used in this trial, with needle penetration.<br>* Other names: verum acupuncture;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants reporting complete absence of dyspeptic symptoms |  | at 16 weeks after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Functional dyspepsia, postprandial distress syndrome