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Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

This study has been terminated.
(no eligible subjects identified during recruitment)
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by:
Penn State University
ClinicalTrials.gov Identifier:
NCT00219505
First received: September 14, 2005
Last updated: June 1, 2011
Last verified: September 2006
History of Changes

September 14, 2005
June 1, 2011
August 2001
Not Provided
Frequency of bowel movement
Same as current
Complete list of historical versions of study NCT00219505 on ClinicalTrials.gov Archive Site
Abdominal pain
Same as current
Not Provided
Not Provided
 
Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
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.

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

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
Irritable Bowel Syndrome
Procedure: acupuncture
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
36
January 2004
Not Provided

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00219505
2000-343
Not Provided
Not Provided
Penn State University
American College of Gastroenterology
Principal Investigator: Ann Ouyangm, MD Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
Penn State University
September 2006

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