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OpenTrials
Completed

NCT Number: NCT02079857

Symptom Management for Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Division of Special Studies in Symptom Management

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard protocol

Other

Subjects will receive a standard treatment

Individualized protocol

Other

Subjects will receive an individualized treatment

Sham acupuncture/Placebo moxa

Other

Subjects will receive sham acupuncture/placebo moxa

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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2014
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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