Acupuncture for Patients With Function Dyspepsia

Phase III Study of Acupuncture for Patients With Functional Dyspepsia

Hypothesis: Acupuncture is efficacious and safe for patients with functional dyspepsia

Design:

  • A single blind randomized controlled trial
  • 200 participants will be included
  • Two arms: acupuncture and sham acupuncture group

Study Overview

Detailed Description

Aim: to clarify the efficacy and safety of acupuncture for patients with functional dyspepsia Design: A single blind randomized controlled trial will be performed in Chengdu, Hunan and Chongqing province. Two hundred participants will be randomly assign to acupuncture and sham acupuncture group. Each participants will receive 20 sessions of acupuncture in 4 weeks, with a duration of 30 minutes in a session. The primary outcome is Patients' global assessments of efficacy in 16 weeks after inclusion. Secondary outcomes include validated Leeds Dyspepsia Questionnaire, Nepean dyspepsia index, etc.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Sichuan
      • Chengdu, Sichuan, China, 610075
        • Chengdu University of TCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)
  • Include postprandial distress syndrome.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: acupuncture group
use traditional acupuncture to treat functional dyspepsia
In this group, acupuncture is given according to traditional acupuncture theories.
Other Names:
  • use hwato acupuncture needles
SHAM_COMPARATOR: sham acupuncture group
use penetrating sham acupuncture to manage functional dyspepsia
Sham acupuncture points will be used in this trial, with needle penetration.
Other Names:
  • verum acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of participants reporting complete absence of dyspeptic symptoms
Time Frame: at 16 weeks after inclusion
at 16 weeks after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
validated Leeds Dyspepsia Questionnaire
Time Frame: 4, 8, 16, 20, 24 weeks after inclusion
4, 8, 16, 20, 24 weeks after inclusion
Nepean dyspepsia index
Time Frame: 4, 8, 16, 20, 24 weeks after inclusion
4, 8, 16, 20, 24 weeks after inclusion
adverse events in each group
Time Frame: 4 weeks after inclusion
4 weeks after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Fan-rong Liang, MD, Chengdu University of TCM

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

November 1, 2014

Study Registration Dates

First Submitted

August 21, 2012

First Submitted That Met QC Criteria

August 21, 2012

First Posted (ESTIMATE)

August 23, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 2, 2014

Last Update Submitted That Met QC Criteria

November 25, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012CB518501-3
  • 2012CB518501 (OTHER_GRANT: The Chinese Ministry of science and technology)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Functional Dyspepsia

Clinical Trials on acupuncture

3
Subscribe