Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

November 8, 2011 updated by: Chengdu University of Traditional Chinese Medicine
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."

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

720

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group 1
specific acupoints of Stomach meridians
Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Experimental: group 2
Non-specific acupoints of Stomach meridians
Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Experimental: group 3
alarm and transport points
Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Experimental: group 4
acupoints of the other meridian
Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Sham Comparator: group 5
non-acupoints
Other: acupuncture
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Active Comparator: group 6
Itopride
Drug: Itopride
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.
Other Names:
  • Itopride Hydrochloride Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Nepean Dyspepsia Index
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Symptoms Index of Dyspepsia
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu University of Traditional Chinese Medicine

Investigators

  • Study Chair: Fan-rong Liang, master, Chengdu University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

January 4, 2008

First Submitted That Met QC Criteria

January 23, 2008

First Posted (Estimate)

January 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2011

Last Update Submitted That Met QC Criteria

November 8, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006CB5045012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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