Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Functional Dyspepsia

Treatments: Other: acupuncture; Drug: Itopride

Study type: Interventional

Funder types: Other

Identifiers

NCT00599677

2006CB5045012

Details and patient eligibility

About

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."

Full 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."

Enrollment: 720 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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720 participants in 6 patient groups

group 1

Experimental group

Description:

specific acupoints of Stomach meridians

Treatment:

Other: acupuncture

group 2

Experimental group

Description:

Non-specific acupoints of Stomach meridians

Treatment:

Other: acupuncture

group 3

Experimental group

Description:

alarm and transport points

Treatment:

Other: acupuncture

group 4

Experimental group

Description:

acupoints of the other meridian

Treatment:

Other: acupuncture

group 5

Sham Comparator group

Description:

non-acupoints

Treatment:

Other: acupuncture

group 6

Active Comparator group

Description:

Itopride

Treatment:

Drug: Itopride