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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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Treatment of Functional Dyspepsia With Acupuncture: A Randomized, Blinded, Sham Acupuncture Controlled Study

Resource links provided by NLM:


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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acupuncture
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 Comparator: Sham acupuncture
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Singapore
National University Hospital
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Khek Yu Ho, MD National University Hospital, Singapore
  More Information

No publications provided

Responsible Party: Medicine, Professor & Senior Consultant Gastroenterologist, Ho Khek Yu, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00786214     History of Changes
Other Study ID Numbers: D/06/479
Study First Received: November 4, 2008
Last Updated: June 20, 2013
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Functional Dyspepsia
Acupuncture
Traditional Chinese Medicine

Additional relevant MeSH terms:
Dyspepsia
Gastritis
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Stomach Diseases

ClinicalTrials.gov processed this record on November 19, 2014