Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT00599677
First received: January 4, 2008
Last updated: November 8, 2011
Last verified: November 2011
  Purpose

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."


Condition Intervention
Functional Dyspepsia
Other: acupuncture
Drug: Itopride

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Resource links provided by NLM:


Further study details as provided by Chengdu University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • Nepean Dyspepsia Index [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptoms Index of Dyspepsia [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 720
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Itopride Hydrochloride Tablets

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."

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599677

Locations
China, Sichuan
Chengdu University of TCM
Chengdu, Sichuan, China, 610075
Sponsors and Collaborators
Chengdu University of Traditional Chinese Medicine
Investigators
Study Chair: Fan-rong Liang, master Chengdu University of TCM
  More Information

No publications provided by Chengdu University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT00599677     History of Changes
Other Study ID Numbers: 2006CB5045012, 2006CB5045012
Study First Received: January 4, 2008
Last Updated: November 8, 2011
Health Authority: China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:
acupuncture
meridian
acupoint

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on August 20, 2014