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Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
acupuncture
Itopride
Sponsored by
Chengdu University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring acupuncture, meridian, acupoint

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Sham Comparator

Active Comparator

Arm Label

group 1

group 2

group 3

group 4

group 5

group 6

Arm Description

specific acupoints of Stomach meridians

Non-specific acupoints of Stomach meridians

alarm and transport points

acupoints of the other meridian

non-acupoints

Itopride

Outcomes

Primary Outcome Measures

Nepean Dyspepsia Index

Secondary Outcome Measures

Symptoms Index of Dyspepsia

Full Information

First Posted
January 4, 2008
Last Updated
November 8, 2011
Sponsor
Chengdu University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00599677
Brief Title
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Official Title
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
acupuncture, meridian, acupoint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
720 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
Experimental
Arm Description
specific acupoints of Stomach meridians
Arm Title
group 2
Arm Type
Experimental
Arm Description
Non-specific acupoints of Stomach meridians
Arm Title
group 3
Arm Type
Experimental
Arm Description
alarm and transport points
Arm Title
group 4
Arm Type
Experimental
Arm Description
acupoints of the other meridian
Arm Title
group 5
Arm Type
Sham Comparator
Arm Description
non-acupoints
Arm Title
group 6
Arm Type
Active Comparator
Arm Description
Itopride
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
Subjects are treated five days a week continuously, and for four weeks.They are treated 30min every time.
Intervention Type
Drug
Intervention Name(s)
Itopride
Other Intervention Name(s)
Itopride Hydrochloride Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nepean Dyspepsia Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Symptoms Index of Dyspepsia
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan-rong Liang, master
Organizational Affiliation
Chengdu University of TCM
Official's Role
Study Chair
Facility Information:
Facility Name
Chengdu University of TCM
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610075
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
26021959
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.
Results Reference
derived
PubMed Identifier
21435214
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.
Results Reference
derived
PubMed Identifier
19698147
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.
Results Reference
derived

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Randomized Controlled Trial of Acupuncture for Functional Dyspepsia

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