Treatment of Functional Dyspepsia With Acupuncture

NCT00786214 | Completed

• 1 other identifier: D/06/479
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Keywords

Functional Dyspepsia; Acupuncture; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Resolution of symptoms

  4 weeks

Secondary Outcomes (1)

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

  4 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

Patients given acupuncture treatment

Other: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Patients given sham acupuncture treatment

Other: Sham acupuncture

Interventions

Acupuncture OTHER

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

Acupuncture

Sham acupuncture OTHER

Patients will be given sham acupuncture treatment at dummy acupuncture points

Sham acupuncture

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, 119074, Singapore

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Khek Yu Ho, MD

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Senior Consultant Gastroenterologist, Ho Khek Yu

Study Record Dates

• First Submitted: November 4, 2008
• First Posted: November 6, 2008
• Study Start: February 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

SG (1)