Treatment of Functional Dyspepsia With Acupuncture

This study has been completed.

Sponsor:

Information provided by:

National University Hospital, Singapore

ClinicalTrials.gov Identifier:

NCT00786214

First received: November 4, 2008

Last updated: March 2, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

November 4, 2008

Last Updated Date

March 2, 2011

Start Date ^ICMJE

February 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Resolution of symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00786214 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Health-related quality of life and hospital anxiety & depression scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Treatment of Functional Dyspepsia With Acupuncture

Official Title ^ICMJE

Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Nonulcer Dyspepsia

Intervention ^ICMJE

Other: Acupuncture
Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists
Other: Sham acupuncture
Patients will be given sham acupuncture treatment at dummy acupuncture points

Study Arm (s)

Experimental: Acupuncture
Patients given acupuncture treatment

Intervention: Other: Acupuncture
Sham Comparator: Sham acupuncture
Patients given sham acupuncture treatment

Intervention: Other: Sham acupuncture

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Singapore

Administrative Information

NCT Number ^ICMJE

NCT00786214

Other Study ID Numbers ^ICMJE

D/06/479

Has Data Monitoring Committee

Responsible Party

Khek Yu Ho / Professor, National University Hospital, Singapore

Study Sponsor ^ICMJE

National University Hospital, Singapore

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Khek Yu Ho, MD

National University Hospital, Singapore

Information Provided By

National University Hospital, Singapore

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top