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New York |
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State:
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NY |
| Zip Code: |
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10010 |
| Conditions: |
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Irritable Bowel Syndrome |
| Purpose: |
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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 Syndrome (IBS) in persons between the ages of 18 to 70 years.
IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal
(GI) tract, associated with defecation or a change in bowel patterns and with features of
disordered defecation. Current therapies include dietary modification, psychotherapy and
pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to
symptom management that is subtle, holistic and holds promise as an intervention for IBS.
This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by
the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental
intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2,
subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham
Acupuncture/Placebo Moxibustion(control group).
Subjects will attend a screening/intake session followed by two treatment sessions per week
for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up
sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist
(blinded to treatment assignments), receive interventions appropriate to their condition
assignment by treating acupuncturists, be administered the same instruments, and submit
their symptom diaries for data entry and analysis. All subjects will complete a prospective
symptom diary for the duration of the study.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- 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 Criteria:
- 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. |
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| Study is available at: |
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New York University, Division of Special Studies in Symptom Management
New York, NY 10010
United States
Primary Contact:
Ann M Chung
Email: amc20@nyu.edu
Phone: 212-305-7038
Secondary Contact:
Ann M Chung
Email: amc20@nyu.edu
Phone: 212-922-7038 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 23, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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