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
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00219505     History of Changes
Other Study ID Numbers: 2000-343
Study First Received: September 14, 2005
Last Updated: June 1, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Diarrhea
Irritable Bowel Syndrome
Syndrome
Colonic Diseases
Colonic Diseases, Functional
Digestive System Diseases
Disease
Gastrointestinal Diseases
Intestinal Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 23, 2014