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CompletedNCT02079857Updated Jul 28, 2020

Symptom Management for Irritable Bowel Syndrome

An interventional study of Standard protocol and Individualized protocol in Irritable Bowel Syndrome, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 4 months after the study started (first participant enrolled Nov 2012, registered Mar 2014).
Phase
Not applicable
Study type
Interventional
Enrollment
183
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Irritable Bowel Syndrome
03

In context

Irritable Bowel Syndrome

1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.

This study's enrollment of 183 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.

Browse Irritable Bowel Syndrome studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
183 participants (actual)

Study arms

  • Experimental
    Standard

    Fixed protocol

    Other: Standard protocol

  • Experimental
    Individualized

    Individualized protocol

    Other: Individualized protocol

  • Sham comparator
    Control

    Sham acupuncture/Placebo moxa

    Other: Sham acupuncture/Placebo moxa

Interventions

  • OtherStandard protocol

    Subjects will receive a standard treatment

  • OtherIndividualized protocol

    Subjects will receive an individualized treatment

  • OtherSham acupuncture/Placebo moxa

    Subjects will receive sham acupuncture/placebo moxa

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 site
  • NYU Division of Special Studies in Symptom Management
    New York, New York 10010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02079857
Lead sponsor
NYU Langone Health
Collaborators
National Institute of Nursing Research (NINR)
Responsible party
Sponsor
First posted
Mar 6, 2014
Start date
Nov 2012
Primary completion
Nov 1, 2019
Completion
Nov 1, 2019
Last update
Jul 28, 2020

Study contacts

Joyce K Anastasi, PhD
principal investigator · New York University
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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