Symptom Management for Irritable Bowel Syndrome

NCT ID: NCT02079857

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2019-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Standard

Fixed protocol

Group Type EXPERIMENTAL

Standard protocol

Intervention Type OTHER

Subjects will receive a standard treatment

Individualized

Individualized protocol

Group Type EXPERIMENTAL

Individualized protocol

Intervention Type OTHER

Subjects will receive an individualized treatment

Control

Sham acupuncture/Placebo moxa

Group Type SHAM_COMPARATOR

Sham acupuncture/Placebo moxa

Intervention Type OTHER

Subjects will receive sham acupuncture/placebo moxa

Interventions

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Standard protocol

Subjects will receive a standard treatment

Intervention Type OTHER

Individualized protocol

Subjects will receive an individualized treatment

Intervention Type OTHER

Sham acupuncture/Placebo moxa

Subjects will receive sham acupuncture/placebo moxa

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce K Anastasi, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University

Locations

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NYU Division of Special Studies in Symptom Management

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R01NR013695

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-02325

Identifier Type: -

Identifier Source: org_study_id

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