Treatment of Functional Dyspepsia With Acupuncture - Full Text View

Sponsored by:	National University Hospital, Singapore
Information provided by:	National University Hospital, Singapore
ClinicalTrials.gov Identifier:	NCT00786214

Purpose

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.

Condition	Intervention
Functional Dyspepsia	Other: Acupuncture Other: Sham acupuncture

MedlinePlus related topics: Acupuncture Indigestion

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	42
Study Start Date:	February 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00786214

Contacts

Contact: Khek Yu Ho, MD

65-67724362

Locations

Singapore
National University Hospital	Recruiting
Singapore, Singapore, 119074
Contact: Siok Chiang Fan 65-67724084 mdcfsc@nus.edu.sg
Principal Investigator: Khek Yu Ho, MD

Sponsors and Collaborators

National University Hospital, Singapore

Investigators

Principal Investigator:

Khek Yu Ho, MD

National University Hospital, Singapore

More Information

Responsible Party:	National University Hospital, Singapore ( Khek Yu Ho / Professor )
Study ID Numbers:	D/06/479
Study First Received:	November 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00786214
Health Authority:	Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:

Functional Dyspepsia
Acupuncture
Traditional Chinese Medicine

Study placed in the following topic categories:

Signs and Symptoms
Stomach Diseases
Digestive System Diseases
Signs and Symptoms, Digestive

Gastrointestinal Diseases
Gastroenteritis
Dyspepsia
Gastritis

ClinicalTrials.gov processed this record on January 16, 2009