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Acupuncture for Patients With Function Dyspepsia

Primary Purpose

Functional Dyspepsia, Postprandial Distress Syndrome

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
acupuncture
sham acupuncture
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 Functional dyspepsia, postprandial distress syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Chengdu University of TCM

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

acupuncture group

sham acupuncture group

Arm Description

use traditional acupuncture to treat functional dyspepsia

use penetrating sham acupuncture to manage functional dyspepsia

Outcomes

Primary Outcome Measures

The proportion of participants reporting complete absence of dyspeptic symptoms

Secondary Outcome Measures

validated Leeds Dyspepsia Questionnaire
Nepean dyspepsia index
adverse events in each group

Full Information

First Posted
August 21, 2012
Last Updated
November 25, 2014
Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine, Chongqing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01671670
Brief Title
Acupuncture for Patients With Function Dyspepsia
Official Title
Phase III Study of Acupuncture for Patients With Functional Dyspepsia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu University of Traditional Chinese Medicine
Collaborators
Hunan University of Traditional Chinese Medicine, Chongqing Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia, Postprandial Distress Syndrome
Keywords
Functional dyspepsia, postprandial distress syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
use traditional acupuncture to treat functional dyspepsia
Arm Title
sham acupuncture group
Arm Type
Sham Comparator
Arm Description
use penetrating sham acupuncture to manage functional dyspepsia
Intervention Type
Other
Intervention Name(s)
acupuncture
Other Intervention Name(s)
use hwato acupuncture needles
Intervention Description
In this group, acupuncture is given according to traditional acupuncture theories.
Intervention Type
Other
Intervention Name(s)
sham acupuncture
Other Intervention Name(s)
verum acupuncture
Intervention Description
Sham acupuncture points will be used in this trial, with needle penetration.
Primary Outcome Measure Information:
Title
The proportion of participants reporting complete absence of dyspeptic symptoms
Time Frame
at 16 weeks after inclusion
Secondary Outcome Measure Information:
Title
validated Leeds Dyspepsia Questionnaire
Time Frame
4, 8, 16, 20, 24 weeks after inclusion
Title
Nepean dyspepsia index
Time Frame
4, 8, 16, 20, 24 weeks after inclusion
Title
adverse events in each group
Time Frame
4 weeks after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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） 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fan-rong Liang, MD
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
22243034
Citation
Ma TT, Yu SY, Li Y, Liang FR, Tian XP, Zheng H, Yan J, Sun GJ, Chang XR, Zhao L, Wu X, Zeng F. Randomised clinical trial: an assessment of acupuncture on specific meridian or specific acupoint vs. sham acupuncture for treating functional dyspepsia. Aliment Pharmacol Ther. 2012 Mar;35(5):552-61. doi: 10.1111/j.1365-2036.2011.04979.x. Epub 2012 Jan 16.
Results Reference
background
PubMed Identifier
23901030
Citation
Zheng H, Xu J, Li J, Li X, Zhao L, Chang X, Liu M, Gong B, Li X, Liang F. Acupuncture for patients with functional dyspepsia: study protocol of a randomised controlled trial. BMJ Open. 2013 Jul 30;3(7):e003377. doi: 10.1136/bmjopen-2013-003377.
Results Reference
derived

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Acupuncture for Patients With Function Dyspepsia

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