|
|
|
|
|
|
Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00093327 |
The purpose of this study is to determine whether acupuncture is effective in reducing the symptoms of irritable bowel syndrome (IBS).
Condition | Intervention | Phase |
Irritable Bowel Syndrome |
Procedure: Acupuncture |
Phase II |
MedlinePlus related topics: | Acupuncture |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Acupuncture for Irritable Bowel Syndrome (IBS) Trial |
Estimated Enrollment: | 287 |
Study Start Date: | September 2003 |
Estimated Study Completion Date: | April 2006 |
IBS is a disorder that affects colon functioning. Although it does not cause permanent harm or lead to more serious conditions, IBS can cause a great deal of discomfort and distress. The effectiveness of acupuncture in treating various conditions has been investigated in numerous studies. However, little is known about acupuncture's efficacy in treating IBS. This study will determine whether acupuncture can alleviate the symptoms of IBS, including pain relief with defecation, changes in stools, and changes in the frequency of bowel movements.
Participants in this study will be randomly assigned to receive bi-weekly sessions of either active or placebo acupuncture or no treatment for 6 weeks. Study visits will occur at study start, Week 3, and Week 6 (study completion). At each study visit, blood collection will occur to measure levels of cortisol, a stress hormone associated with IBS. Participants will also complete questionnaires about their IBS symptoms. Selected participants will be interviewed at each visit, in order to determine whether participants' interpretations and understanding of IBS influences their response to treatment. Any subject who does not receive active acupuncture during the trial is eligible for 6 free acupuncture treatments after the study is over.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center, General Clinical Research Center | |||||
Boston, Massachusetts, United States, 02215 |
National Center for Complementary and Alternative Medicine (NCCAM) |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Principal Investigator: | Ted Kaptchuk, OMD | Beth Israel Deaconess Medical Center |
Study ID Numbers: | R01 AT001414-01 |
First Received: | October 6, 2004 |
Last Updated: | August 17, 2006 |
ClinicalTrials.gov Identifier: | NCT00093327 |
Health Authority: | United States: Federal Government |
|
|
|