- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02079857
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
-
-
New York
-
New York, New York, United States, 10010
- NYU Division of Special Studies in Symptom Management
-
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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
|
Subjects will receive a standard treatment
|
EXPERIMENTAL: Individualized
Individualized protocol
|
Subjects will receive an individualized treatment
|
SHAM_COMPARATOR: Control
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
Collaborators
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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