Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
Primary Purpose
Irritable Bowel Syndrome
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Diarrhea-predominant irritable bowel syndrome, Acupuncture, abdominal pain
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
Sites / Locations
- Hershey Medical Center
Outcomes
Primary Outcome Measures
Frequency of bowel movement
Secondary Outcome Measures
Abdominal pain
Full Information
NCT ID
NCT00219505
First Posted
September 14, 2005
Last Updated
November 21, 2017
Sponsor
Penn State University
Collaborators
American College of Gastroenterology
1. Study Identification
Unique Protocol Identification Number
NCT00219505
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
no eligible subjects identified during recruitment
Study Start Date
August 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penn State University
Collaborators
American College of Gastroenterology
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Diarrhea-predominant irritable bowel syndrome, Acupuncture, abdominal pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
36 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
acupuncture
Primary Outcome Measure Information:
Title
Frequency of bowel movement
Secondary Outcome Measure Information:
Title
Abdominal pain
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Ouyangm, MD
Organizational Affiliation
Penn State College of Medicine and Penn State Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
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Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS
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