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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
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Other: Standard protocol Other: Individualized protocol Other: Sham acupuncture/Placebo moxa Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Symptom severity-abdominal pain [ Time Frame: week 1 ]
  2. Symptom severity-abdominal pain [ Time Frame: week 4 ]
  3. Symptom severity-abdominal pain [ Time Frame: week 8 ]
  4. Symptom severity-abdominal pain [ Time Frame: week 12 ]
  5. Symptom severity-abdominal pain [ Time Frame: week 24 ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, New York
NYU Division of Special Studies in Symptom Management
New York, New York, United States, 10010
Sponsors and Collaborators
NYU Langone Health
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Joyce K Anastasi, PhD New York University
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02079857    
Other Study ID Numbers: 12-02325
R01NR013695 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2014    Key Record Dates
Last Update Posted: July 28, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
 Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases