Randomized Controlled Trial of Treating Functional Dyspepsia With Acupuncture - Full Text View

Sponsored by:	Chengdu University of Traditional Chinese Medicine
Information provided by:	Chengdu University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:	NCT00599677

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

MedlinePlus related topics: Acupuncture Indigestion

Drug Information available for: Itopride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomized Controlled Trial of Treating Functional Dyspepsia With Acupuncture

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 ]

Estimated Enrollment:	720
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: Experimental 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.
3: Experimental alarm and transport points	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
4: Experimental 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.
5: Sham Comparator non-acupoints	Other: acupuncture Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
6: Active Comparator 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.

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:

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

Exclusion Criteria:

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

Contacts and Locations

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

Contacts

Contact: Liang F rong, master

8613608058216

acuresearch@126.com

Locations

China, SiChuan
Chengdu University of TCM	Recruiting
Chengdu, SiChuan, China, 610075
Contact: Liang F rong, master 8613608058216 acuresearch@126.com
Sub-Investigator: Tian X ping, MD

Sponsors and Collaborators

Chengdu University of Traditional Chinese Medicine

Investigators

Study Chair:

Liang F rong, master

Chengdu University of TCM

More Information

Responsible Party:	Acupuncture & Tuina college of chengdu univeristy of TCM ( Liang Fanrong )
Study ID Numbers:	2006CB5045012, 2006CB5045012
Study First Received:	January 4, 2008
Last Updated:	December 27, 2008
ClinicalTrials.gov Identifier:	NCT00599677
Health Authority:	China: Ethics Committee

Keywords provided by Chengdu University of Traditional Chinese Medicine:

acupuncture
meridian
acupoint

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 14, 2009