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| 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: | Irritable Bowel Syndrome |
| ChemIDplus related topics: | Serotonin |
| 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. |
| Estimated Enrollment: | 36 |
| Study Start Date: | August 2001 |
| Estimated Study Completion Date: | January 2004 |
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Pennsylvania | |||||
| Hershey Medical Center | |||||
| Hershey, Pennsylvania, United States, 17033 | |||||
| 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 |
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 |
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