Treatment of Functional Dyspepsia With Acupuncture

NCT ID: NCT00786214

Last Updated: 2013-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-02-28
• Study Completion Date: 2009-12-31

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.

Conditions

Functional Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Acupuncture

Patients given acupuncture treatment

Group Type: EXPERIMENTAL

Acupuncture

Intervention Type: OTHER

Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists

Sham acupuncture

Patients given sham acupuncture treatment

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: OTHER

Patients will be given sham acupuncture treatment at dummy acupuncture points

Interventions

Acupuncture

Patients will be stimulated at specific acupuncture points as determined for treatment of the disease by certified acupuncturists

Intervention Type: OTHER

Sham acupuncture

Patients will be given sham acupuncture treatment at dummy acupuncture points

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Medicine

Professor & Senior Consultant Gastroenterologist, Ho Khek Yu

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Khek Yu Ho, MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

National University Hospital

Singapore, , Singapore

Countries

Singapore

Other Identifiers

D/06/479

Identifier Type: -

Identifier Source: org_study_id