Irritable Bowel Syndrome Clinical Trial
Official title:
Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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