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NCT00219505 Clinical Trial

Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

Irritable Bowel Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00219505
Other study ID # 2000-343
Secondary ID
Status Terminated
Phase N/A
First received September 14, 2005
Last updated November 21, 2017
Start date August 2001
Est. completion date January 2004

Study information
Verified date November 2017
Source Penn State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 36
Est. completion date January 2004
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• acupuncture

Locations
Country Name City State
United States Hershey Medical Center Hershey Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Penn State University American College of Gastroenterology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Frequency of bowel movement
Secondary Abdominal pain
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