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Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

This study has been terminated.

Sponsors and Collaborators: Penn State University
American College of Gastroenterology
Information provided by: Penn State University
ClinicalTrials.gov Identifier: NCT00219505
  Purpose

Acupuncture has been used for centuries in China in the treatment of diarrhea. Our hypothesis is that acupuncture is effective in the treatment of abdominal pain and diarrhea in patients with diarrhea-predominant IBS


Condition Intervention
Irritable Bowel Syndrome
Procedure: acupuncture

MedlinePlus related topics:   Abdominal Pain   Acupuncture   Diarrhea  

ChemIDplus related topics:   Serotonin  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study
Official Title:   Effect of Acupuncture on Symptoms of Diarrhea and Pain in Diarrhea Predominant Irritable Bowel Syndrome (IBS) and Effect on Plasma Beta-Endorphin and Serotonin Levels.

Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Frequency of bowel movement

Secondary Outcome Measures:
  • Abdominal pain

Estimated Enrollment:   36
Study Start Date:   August 2001
Estimated Study Completion Date:   January 2004

Detailed Description:

Patients will complete a diary to determine if they qualify for the study. Patients will be randomized to receive either acupuncture or sham acupuncture (needle insertion 1 cm away from acupuncture site). Patients will be blinded to whether they are receiving acupuncture or sham acupuncture. The acupuncturist is blinded as to the patient response. The patients will undergo venupuncture to draw blood to determine sertotonin and beta-endorphin levels. They will receive treatment in 12 sessions over 4 weeks. They will maintain a diary during this time period to document level of pain and frequency of bowel movements. Blood will be drawn at week 2 and 4 and, 6 weeks after cessation of treatment, subjects will again record abdominal symptoms and frequency of bowel movements for 2 weeks. Blood will be drawn for hormone levels at 8 weeks after completion of study.

  Eligibility
Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • frequence of bowel movement of at least 3/day
  • global disease severity of at least 3

Exclusion Criteria:

  • taking medications which will influence frequency of bowel movement
  • patient taking anticoagulants or suffering from coagulopathy
  • pregancy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219505

Locations
United States, Pennsylvania
Hershey Medical Center    
      Hershey, Pennsylvania, United States, 17033

Sponsors and Collaborators
Penn State University
American College of Gastroenterology

Investigators
Principal Investigator:     Ann Ouyangm, MD     Penn State College of Medicine and Penn State Milton S. Hershey Medical Center    
  More Information

Study ID Numbers:   2000-343
First Received:   September 14, 2005
Last Updated:   September 7, 2006
ClinicalTrials.gov Identifier:   NCT00219505
Health Authority:   United States: Institutional Review Board

Keywords provided by Penn State University:
Diarrhea-predominant irritable bowel syndrome  
Acupuncture  
abdominal pain  

Study placed in the following topic categories:
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Abdominal Pain
Colonic Diseases
Irritable Bowel Syndrome
Pain
Intestinal Diseases
Colonic Diseases, Functional
Serotonin

Additional relevant MeSH terms:
Signs and Symptoms
Pathologic Processes
Disease
Digestive System Diseases
Syndrome

ClinicalTrials.gov processed this record on July 03, 2008




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