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Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

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ClinicalTrials.gov Identifier: NCT00599677
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : November 9, 2011
Sponsor:
Information provided by (Responsible Party):
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."

Condition or disease Intervention/treatment Phase
Functional Dyspepsia Other: acupuncture Drug: Itopride Not Applicable

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  (Clinical Trial)
Actual Enrollment : 720 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Study Start Date : November 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


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 Name: Itopride Hydrochloride Tablets




Primary Outcome Measures :
  1. Nepean Dyspepsia Index [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Symptoms Index of Dyspepsia [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2011

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