Clinical trial NCT00599677: Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Official title: Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Dyspepsia
Keywords: acupuncture
meridian
acupoint
Lead sponsor: Chengdu University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 720
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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."

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 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.

Primary outcomes:
measure: Nepean Dyspepsia Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Symptoms Index of Dyspepsia
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Chengdu University of TCM
state: Sichuan
Study officials:
affiliation: Chengdu University of TCM
name: Fan-rong Liang, master
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.