Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS - Tabular View

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Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

This study has been terminated.
Information provided by Penn State University

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

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.

Brief 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

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study

Primary Outcome Measure ^†

Frequency of bowel movement

Secondary Outcome Measure ^†

Abdominal pain

Condition ^†

Irritable Bowel Syndrome

Intervention ^†

Procedure: acupuncture

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Terminated

Enrollment ^†

Start Date ^†

August 2001

Completion Date

January 2004

Eligibility 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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00219505

Organization ID

2000-343

Secondary IDs ^††

Study Sponsor ^†

Penn State University

Collaborators ^††

American College of Gastroenterology

Investigators ^†

Principal Investigator:

Ann Ouyangm, MD

Penn State College of Medicine and Penn State Milton S. Hershey Medical Center

Information Provided By

Penn State University

Verification Date

September 2006

First Received Date ^†

September 14, 2005

Last Updated Date

September 7, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.