Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

NCT ID: NCT00599677

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

720 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-09-30

Brief Summary

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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

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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."

Conditions

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Functional Dyspepsia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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group 1

specific acupoints of Stomach meridians

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

group 2

Non-specific acupoints of Stomach meridians

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

group 3

alarm and transport points

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

group 4

acupoints of the other meridian

Group Type EXPERIMENTAL

acupuncture

Intervention Type OTHER

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

group 5

non-acupoints

Group Type SHAM_COMPARATOR

acupuncture

Intervention Type OTHER

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

group 6

Itopride

Group Type ACTIVE_COMPARATOR

Itopride

Intervention Type DRUG

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.

Interventions

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acupuncture

Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.

Intervention Type OTHER

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.

Intervention Type DRUG

Other Intervention Names

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Itopride Hydrochloride Tablets

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fan-rong Liang, master

Role: STUDY_CHAIR

Chengdu University of TCM

Locations

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Chengdu University of TCM

Chengdu, Sichuan, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 26021959 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21435214 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19698147 (View on PubMed)

Other Identifiers

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2006CB5045012

Identifier Type: -

Identifier Source: secondary_id

2006CB5045012

Identifier Type: -

Identifier Source: org_study_id