Symptom Management for Irritable Bowel Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02079857|
Recruitment Status : Completed
First Posted : March 6, 2014
Last Update Posted : July 28, 2020
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|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome||Other: Standard protocol Other: Individualized protocol Other: Sham acupuncture/Placebo moxa||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Symptom Management for Irritable Bowel Syndrome|
|Actual Study Start Date :||November 2012|
|Actual Primary Completion Date :||November 1, 2019|
|Actual Study Completion Date :||November 1, 2019|
Other: Standard protocol
Subjects will receive a standard treatment
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
- Symptom severity-abdominal pain [ Time Frame: week 1 ]
- Symptom severity-abdominal pain [ Time Frame: week 4 ]
- Symptom severity-abdominal pain [ Time Frame: week 8 ]
- Symptom severity-abdominal pain [ Time Frame: week 12 ]
- Symptom severity-abdominal pain [ Time Frame: week 24 ]
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|Ages Eligible for Study:||18 Years to 70 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02079857
|United States, New York|
|NYU Division of Special Studies in Symptom Management|
|New York, New York, United States, 10010|
|Principal Investigator:||Joyce K Anastasi, PhD||New York University|
|Responsible Party:||NYU Langone Health|
|Other Study ID Numbers:||
R01NR013695 ( U.S. NIH Grant/Contract )
|First Posted:||March 6, 2014 Key Record Dates|
|Last Update Posted:||July 28, 2020|
|Last Verified:||July 2020|
Irritable Bowel Syndrome
Colonic Diseases, Functional
Digestive System Diseases