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NCT02079857 Clinical Trial

Symptom Management for Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:
Symptom Management for Irritable Bowel Syndrome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02079857
Other study ID # 12-02325
Secondary ID R01NR013695
Status Completed
Phase N/A
First received
Last updated
Start date November 2012
Est. completion date November 1, 2019

Study information
Verified date July 2020
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 183
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• Standard protocol
Subjects will receive a standard treatment
• Individualized protocol
Subjects will receive an individualized treatment
• Sham acupuncture/Placebo moxa
Subjects will receive sham acupuncture/placebo moxa

Locations
Country Name City State
United States NYU Division of Special Studies in Symptom Management New York New York

Sponsors (2)
Lead Sponsor Collaborator
NYU Langone Health National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom severity-abdominal pain week 1
Primary Symptom severity-abdominal pain week 4
Primary Symptom severity-abdominal pain week 8
Primary Symptom severity-abdominal pain week 12
Primary Symptom severity-abdominal pain week 24
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