Symptom Management for Irritable Bowel Syndrome

July 27, 2020 updated by: NYU Langone Health
The objective of this study is to test the efficacy of a symptom management treatment strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • NYU Division of Special Studies in Symptom Management

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women 18 to 70 years of age.
  • Diagnosis of IBS based on ROME III criteria.
  • Complete symptom diaries and return completed diaries at all sessions.

Exclusion Criteria:

  • History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology.
  • Alarm symptoms according to ROME III.
  • Individuals currently receiving other types of complementary therapies.
  • Individuals with an acute medical condition requiring acute medical attention.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standard
Fixed protocol
Other: Standard protocol
Subjects will receive a standard treatment
EXPERIMENTAL: Individualized
Individualized protocol
Other: Individualized protocol
Subjects will receive an individualized treatment
SHAM_COMPARATOR: Control
Sham acupuncture/Placebo moxa
Other: Sham acupuncture/Placebo moxa
Subjects will receive sham acupuncture/placebo moxa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Symptom severity-abdominal pain
Time Frame: week 1
week 1
Symptom severity-abdominal pain
Time Frame: week 4
week 4
Symptom severity-abdominal pain
Time Frame: week 8
week 8
Symptom severity-abdominal pain
Time Frame: week 12
week 12
Symptom severity-abdominal pain
Time Frame: week 24
week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Institute of Nursing Research (NINR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2012

Primary Completion (ACTUAL)

November 1, 2019

Study Completion (ACTUAL)

November 1, 2019

Study Registration Dates

First Submitted

March 3, 2014

First Submitted That Met QC Criteria

March 4, 2014

First Posted (ESTIMATE)

March 6, 2014

Study Record Updates

Last Update Posted (ACTUAL)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 27, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-02325
  • R01NR013695 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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