NCT00945074

Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)

Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 171 (estimated)
• Sponsor: New York University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
OTHER	Standard Acupuncture/Moxibustion (fixed protocol)	Acupuncture/Moxibustion
OTHER	Individualized Acupuncture/Moxibustion	Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis
OTHER	Sham/Placebo Acupuncture/Moxibustion	Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active

Timeline

• Start date: 2009-07-01
• Primary completion: 2017-04-01
• Completion: 2017-12-01
• First posted: 2009-07-23
• Last updated: 2016-09-22

Locations

1 site across 1 country: United States