Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Not Applicable

Completed

• Conditions: Functional Dyspepsia
• Interventions: Other: acupuncture; Drug: Itopride

• Registration Number: NCT00599677
• Lead Sponsor: Chengdu University of Traditional Chinese Medicine

Brief Summary

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

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 that"Acupuncture effect is based on meridians, and gathering of meridian Qi is the key point."

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-01-04
• Study First Submitted QC: 2008-01-23
• Study First Posted: 2008-01-24
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-08
• Last Update Posted: 2011-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

1. Consistent with the diagnostic criteria of functional dyspepsia.
2. Age of a subject is older than 18 and is younger than 65.（including 18 and 65）
3. Did not take any gastroenteric dynamic drugs in the last 15 days, and did not take part in any clinical trial.
4. Informed consent is signed by a subject or his lineal relation.

Exclusion Criteria

1. Patients with any contraindications of Itopride.
2. Patients who are unconscious, psychotic.
3. Patients with aggravating tumor and other serious consumptive disease, and who are subject to infection and bleeding.
4. With serious protopathy or disease of cardiovascular, liver, renal, gastrointestinal, hematological systems and so on.
5. Pregnant women or women in lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	acupuncture	Non-specific acupoints of Stomach meridians
group 3	acupuncture	alarm and transport points
group 4	acupuncture	acupoints of the other meridian
group 1	acupuncture	specific acupoints of Stomach meridians
group 5	acupuncture	non-acupoints
group 6	Itopride	Itopride

Primary Outcome Measures

Name	Time	Method
Nepean Dyspepsia Index	4 weeks

Secondary Outcome Measures

Name	Time	Method
Symptoms Index of Dyspepsia	4 weeks

Trial Locations

Locations (1)

Chengdu University of TCM; 🇨🇳 Chengdu, Sichuan, China