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Treatment of Functional Dyspepsia With Acupuncture

Primary Purpose

Functional Dyspepsia

Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Acupuncture
Sham acupuncture
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia focused on measuring Functional Dyspepsia, Acupuncture, Traditional Chinese Medicine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

- female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity.

Exclusion criteria:

  • Subjects unable to give informed consent
  • Pregnant or breast-feeding females or women who get pregnant midway
  • Subjects who have received acupuncture treatment before
  • Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy
  • Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study
  • Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study
  • Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study
  • H. pylori eradication treatment within the past 12 months before study start
  • H. pylori positive patients
  • Patients with bleeding diathesis
  • Known or suspected hypersensitivity to acupuncture.

Sites / Locations

  • National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture

Sham acupuncture

Arm Description

Patients given acupuncture treatment

Patients given sham acupuncture treatment

Outcomes

Primary Outcome Measures

Resolution of symptoms

Secondary Outcome Measures

Health-related quality of life and hospital anxiety & depression scale

Full Information

First Posted
November 4, 2008
Last Updated
June 20, 2013
Sponsor
National University Hospital, Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00786214
Brief Title
Treatment of Functional Dyspepsia With Acupuncture
Official Title
Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Functional dyspepsia (FD) is one of the most common chronic gastrointestinal disorders affecting humans. Existing therapies for FD are still far from satisfactory and new therapies are constantly being sought. Acupuncture has been used for the alleviation of functional gastrointestinal symptoms in several non-controlled studies. This study aims to investigate the therapeutic efficacy of acupuncture in patients with FD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Functional Dyspepsia
Keywords
Functional Dyspepsia, Acupuncture, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Patients given acupuncture treatment
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Patients given sham acupuncture treatment
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists
Intervention Type
Other
Intervention Name(s)
Sham acupuncture
Intervention Description
Patients will be given sham acupuncture treatment at dummy acupuncture points
Primary Outcome Measure Information:
Title
Resolution of symptoms
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life and hospital anxiety & depression scale
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: - female and male patients with functional dyspepsia between the ages of ≥18 and ≤70 years. FD will be diagnosed according to the Rome-III criteria. Onset of FD symptoms should begin at least 6 months before clinical presentation and must be fulfilled for the last 3 months and his or her FD symptoms score must be of at least moderate severity. Exclusion criteria: Subjects unable to give informed consent Pregnant or breast-feeding females or women who get pregnant midway Subjects who have received acupuncture treatment before Subjects who have had a previous gastrointestinal surgery except appendectomy and laparoscopic cholecystectomy Any significant past or concurrent disease or disorder which, in the opinion of the investigator, may either put subject at risk in the study, influence the results of the study or influence subject's ability to participate in the study Maintenance treatment with PPIs (proton pump inhibitors) and H2RAs (H2-receptor antagonists) continuously (every day) in the last 6 months prior to entry into the study Treatment with PPIs and H2RAs, prokinetics, antibiotics, prostaglandins or bismuth-containing compounds during the last 2 weeks prior to entry into the study H. pylori eradication treatment within the past 12 months before study start H. pylori positive patients Patients with bleeding diathesis Known or suspected hypersensitivity to acupuncture.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khek Yu Ho, MD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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Treatment of Functional Dyspepsia With Acupuncture

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