Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

NCT00599677 — Not applicable, Completed, 720 participants, Chengdu University of Traditional Chinese Medicine

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT00599677
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	720 (Actual)
Sponsor	Chengdu University of Traditional Chinese Medicine (Other)
Conditions	Functional Dyspepsia
Interventions	acupuncture, Itopride (Other, drug)
Dates	start 2007-11-01, primary completion 2009-09-01, completion 2009-09-01, first posted 2008-01-24, last updated 2011-11-09
Locations	1 site in China

-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."

Expand all sections · Collapse all

+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."

+Arms and interventions

Arm	Type	Interventions	Description
group 1	Experimental	Other: acupuncture	specific acupoints of Stomach meridians
group 2	Experimental	Other: acupuncture	Non-specific acupoints of Stomach meridians
group 3	Experimental	Other: acupuncture	alarm and transport points
group 4	Experimental	Other: acupuncture	acupoints of the other meridian
group 5	Sham comparator	Other: acupuncture	non-acupoints
group 6	Active comparator	Drug: Itopride	Itopride

acupuncture (Other): Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Itopride (Drug), also known as Itopride Hydrochloride Tablets: 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.

+Outcome measures

Primary outcomes

Nepean Dyspepsia Index [4 weeks]

Secondary outcomes

Symptoms Index of Dyspepsia [4 weeks]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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.

+Locations (1)

Facility	City	Country	Status
Chengdu University of TCM	Chengdu, Sichuan	China

+Publications

Results publication: Ma T, Zeng F, Li Y, Wang CM, Tian X, Yu S, Zhao L, Wu X, Yang M, Wang D, Liang F. Which subtype of functional dyspepsia patients responses better to acupuncture? A retrospective analysis of a randomized controlled trial. Forsch Komplementmed. 2015;22(2):94-100. doi: 10.1159/000380983. Epub 2015 Mar 11. PMID 26021959
Results publication: Zhao L, Zhang FW, Li Y, Wu X, Zheng H, Cheng LH, Liang FR. Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China. Trials. 2011 Mar 24;12:87. doi: 10.1186/1745-6215-12-87. PMID 21435214
Results publication: Zheng H, Tian XP, Li Y, Liang FR, Yu SG, Liu XG, Tang Y, Yang XG, Yan J, Sun GJ, Chang XR, Zhang HX, Ma TT, Yu SY. Acupuncture as a treatment for functional dyspepsia: design and methods of a randomized controlled trial. Trials. 2009 Aug 23;10:75. doi: 10.1186/1745-6215-10-75. PMID 19698147

+Investigators

Fan-rong Liang, master, Study chair, Chengdu University of TCM

My Notes

Public

To Read Reading Read