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Symptom Management for Irritable Bowel Syndrome

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard protocol
Individualized protocol
Sham acupuncture/Placebo moxa
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • NYU Division of Special Studies in Symptom Management

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Standard

Individualized

Control

Arm Description

Fixed protocol

Individualized protocol

Sham acupuncture/Placebo moxa

Outcomes

Primary Outcome Measures

Symptom severity-abdominal pain
Symptom severity-abdominal pain
Symptom severity-abdominal pain
Symptom severity-abdominal pain
Symptom severity-abdominal pain

Secondary Outcome Measures

Full Information

First Posted
March 3, 2014
Last Updated
July 27, 2020
Sponsor
NYU Langone Health
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT02079857
Brief Title
Symptom Management for Irritable Bowel Syndrome
Official Title
Symptom Management for Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
November 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
Experimental
Arm Description
Fixed protocol
Arm Title
Individualized
Arm Type
Experimental
Arm Description
Individualized protocol
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Sham acupuncture/Placebo moxa
Intervention Type
Other
Intervention Name(s)
Standard protocol
Intervention Description
Subjects will receive a standard treatment
Intervention Type
Other
Intervention Name(s)
Individualized protocol
Intervention Description
Subjects will receive an individualized treatment
Intervention Type
Other
Intervention Name(s)
Sham acupuncture/Placebo moxa
Intervention Description
Subjects will receive sham acupuncture/placebo moxa
Primary Outcome Measure Information:
Title
Symptom severity-abdominal pain
Time Frame
week 1
Title
Symptom severity-abdominal pain
Time Frame
week 4
Title
Symptom severity-abdominal pain
Time Frame
week 8
Title
Symptom severity-abdominal pain
Time Frame
week 12
Title
Symptom severity-abdominal pain
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce K Anastasi, PhD
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Division of Special Studies in Symptom Management
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Symptom Management for Irritable Bowel Syndrome

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