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Condition 1 for Irritable Bowel Syndrome (Acu/MoxaIBS Trial)

Phase 2
Waitlist Available
Led By Joyce K Anastasi, PhD, DrNP, FAAN, LAc
Research Sponsored by New York University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up six months
Awards & highlights

Acu/MoxaIBS Trial 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.

Eligible Conditions
  • Irritable Bowel Syndrome

Acu/MoxaIBS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and six months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
Secondary outcome measures
Global improvement (CGIS)
Psychological Distress
Quality of life (IBS-QOL & SF-36)

Acu/MoxaIBS Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Condition 2: Individualized Acupuncture/MoxibustionExperimental Treatment1 Intervention
Condition 2: Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).
Group II: Condition 1Experimental Treatment1 Intervention
Condition 1: Subjects receive Standard Acu/Moxa (fixed protocol)
Group III: Condition 3: ControlPlacebo Group1 Intervention
Condition 3: Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)

Find a Location

Who is running the clinical trial?

New York UniversityLead Sponsor
226 Previous Clinical Trials
314,084 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,696 Previous Clinical Trials
6,952,408 Total Patients Enrolled
4 Trials studying Irritable Bowel Syndrome
501 Patients Enrolled for Irritable Bowel Syndrome
Joyce K Anastasi, PhD, DrNP, FAAN, LAcPrincipal InvestigatorNew York University

Frequently Asked Questions

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~11 spots leftby Apr 2025