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Status unknownNCT00945074Acu/MoxaIBSUpdated Sep 22, 2016

Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)

A Phase 2 interventional study of Standard Acupuncture/Moxibustion (fixed protocol) and Individualized Acupuncture/Moxibustion in Irritable Bowel Syndrome, sponsored by New York University. Status unknown at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-09-22.

Sponsored by New York University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
171
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome

Keywords

  • Acupuncture
  • Moxibustion
  • Traditional Chinese Medicine
  • Complementary Medicine
  • Irritable Bowel Syndrome
  • IBS
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's planned enrollment of 171 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

New York University is the lead sponsor of 120 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
171 participants (estimated)

Study arms

  • Experimental
    Condition 1

    Condition 1: Subjects receive Standard Acu/Moxa (fixed protocol)

    Other: Standard Acupuncture/Moxibustion (fixed protocol)

  • Experimental
    Condition 2: Individualized Acupuncture/Moxibustion

    Condition 2: Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).

    Other: Individualized Acupuncture/Moxibustion

  • Sham comparator
    Condition 3: Control

    Condition 3: Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)

    Other: Sham/Placebo Acupuncture/Moxibustion

Interventions

  • OtherStandard Acupuncture/Moxibustion (fixed protocol)

    Acupuncture/Moxibustion

  • OtherIndividualized Acupuncture/Moxibustion

    Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis

  • OtherSham/Placebo Acupuncture/Moxibustion

    Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active

06

What researchers measure

Primary outcomes

  1. Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency

    Time frame: Six months

Secondary outcomes

  1. Global improvement (CGIS)

    Time frame: Six months

  2. Quality of life (IBS-QOL & SF-36)

    Time frame: Six months

  3. Psychological distress (SCL-90)

    Time frame: Six months

07

Study locations

1 site
  • New York University, Division of Special Studies in Symptom Management
    New York, New York 10010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00945074
Lead sponsor
New York University
Collaborators
National Institutes of Health (NIH)
Responsible party
Joyce K. Anastasi (Principal Investigator, New York University) — Principal investigator
First posted
Jul 23, 2009
Start date
Jul 2009
Primary completion
Apr 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Sep 22, 2016

Study contacts

Joyce K Anastasi, PhD, DrNP, FAAN, LAc
principal investigator · New York University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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