NCT00599677

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."

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2008

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 9, 2011

Status Verified

November 1, 2011

Enrollment Period

1.8 years

First QC Date

January 4, 2008

Last Update Submit

November 8, 2011

Conditions

Functional Dyspepsia

Keywords

acupuncturemeridianacupoint

Outcome Measures

Primary Outcomes (1)

  • Nepean Dyspepsia Index

    4 weeks

Secondary Outcomes (1)

  • Symptoms Index of Dyspepsia

    4 weeks

Study Arms (6)

group 1

EXPERIMENTAL

specific acupoints of Stomach meridians

Other: acupuncture

group 2

EXPERIMENTAL

Non-specific acupoints of Stomach meridians

Other: acupuncture

group 3

EXPERIMENTAL

alarm and transport points

Other: acupuncture

group 4

EXPERIMENTAL

acupoints of the other meridian

Other: acupuncture

group 5

SHAM COMPARATOR

non-acupoints

Other: acupuncture

group 6

ACTIVE COMPARATOR

Itopride

Drug: Itopride

Interventions

acupunctureOTHER

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

group 1group 2group 3group 4group 5
ItoprideDRUG

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.

Also known as: Itopride Hydrochloride Tablets
group 6

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengdu University of TCM

Chengdu, Sichuan, 610075, China

Location

Related Publications (3)

  • 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: 26021959DERIVED

  • 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: 21435214DERIVED

  • 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: 19698147DERIVED

MeSH Terms

Interventions

Acupuncture Therapyitopride

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Fan-rong Liang, master

    Chengdu University of TCM

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2008

First Posted

January 24, 2008

Study Start

November 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 9, 2011

Record last verified: 2011-11

Locations

CN(1)