Effect of Acupuncture on Symptoms of Diarrhea and Pain in IBS

NCT ID: NCT00219505

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2004-01-31

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Keywords

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Diarrhea-predominant irritable bowel syndrome Acupuncture abdominal pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American College of Gastroenterology

OTHER

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ann Ouyangm, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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2000-343

Identifier Type: -

Identifier Source: org_study_id