Treatment of Functional Dyspepsia With Acupuncture

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00786214
First received: November 4, 2008
Last updated: June 20, 2013
Last verified: June 2013

November 4, 2008
June 20, 2013
February 2007
December 2009   (final data collection date for primary outcome measure)
Resolution of symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00786214 on ClinicalTrials.gov Archive Site
Health-related quality of life and hospital anxiety & depression scale [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Functional Dyspepsia With Acupuncture
Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Functional Dyspepsia
  • 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
  • Experimental: Acupuncture
    Patients given acupuncture treatment
    Intervention: Other: Acupuncture
  • Sham Comparator: Sham acupuncture
    Patients given sham acupuncture treatment
    Intervention: Other: Sham acupuncture
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
December 2009
December 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Singapore
 
NCT00786214
D/06/479
No
Medicine, National University Hospital, Singapore
National University Hospital, Singapore
Not Provided
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
National University Hospital, Singapore
June 2013

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