Symptom Management for Irritable Bowel Syndrome

NYU Langone Health

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Other: Sham acupuncture/Placebo moxa; Other: Individualized protocol; Other: Standard protocol

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02079857

12-02325

R01NR013695 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 183 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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183 participants in 3 patient groups

Standard

Experimental group

Description:

Fixed protocol

Treatment:

Other: Standard protocol

Individualized

Experimental group

Description:

Individualized protocol

Treatment:

Other: Individualized protocol

Control

Sham Comparator group

Description:

Sham acupuncture/Placebo moxa

Treatment:

Other: Sham acupuncture/Placebo moxa