Status:
UNKNOWN
Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)
Lead Sponsor:
New York University
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndr...
Eligibility Criteria
Inclusion
- Men and women 18 to 70 years of age who have a prior diagnosis of IBS (6 months or greater)
- Verification/documentation of subject's diagnosis of IBS (ROME III criteria).
- Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool.
- Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III
- Subjects agree to complete symptom diaries and return completed diaries at all sessions.
- Women of childbearing age must agree to use an acceptable method of contraception.
- Subjects may be on antidepressants(on stable regimen for at least 6 months)
Exclusion
- Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation
- Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance
- Individuals experiencing alarm symptoms according to Rome III
- Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry.
- Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines
- Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki etc.;Individuals receiving behavioral therapies for IBS; Individuals receiving physical therapy for pelvic pain
- Pregnant women.
- Individuals with an acute medical condition, i.e., pneumonia and/or conditions that requiring acute medical attention.
- Individuals with asthma or smoke allergy
- Individuals receiving acupuncture currently and less than 6 months prior to enrollment and/or history of receiving moxibustion
- Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions or recording daily dietary information.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2017
Estimated Enrollment :
171 Patients enrolled
Trial Details
Trial ID
NCT00945074
Start Date
July 1 2009
End Date
December 1 2017
Last Update
September 22 2016
Active Locations (1)
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1
New York University, Division of Special Studies in Symptom Management
New York, New York, United States, 10010