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

Tracking Information

First Received Date ^ICMJE

September 14, 2005

Last Updated Date

September 7, 2006

Start Date ^ICMJE

August 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Frequency of bowel movement

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00219505 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Abdominal pain

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Irritable Bowel Syndrome

Intervention ^ICMJE

Procedure: acupuncture

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

January 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00219505

Responsible Party

Study ID Numbers ^ICMJE

2000-343

Study Sponsor ^ICMJE

Penn State University

Collaborators ^ICMJE

American College of Gastroenterology

Investigators ^ICMJE

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

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP