NCT02079857

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2014

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

7 years

First QC Date

March 3, 2014

Last Update Submit

July 27, 2020

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (5)

  • Symptom severity-abdominal pain

    week 1

  • Symptom severity-abdominal pain

    week 4

  • Symptom severity-abdominal pain

    week 8

  • Symptom severity-abdominal pain

    week 12

  • Symptom severity-abdominal pain

    week 24

Study Arms (3)

Standard

EXPERIMENTAL

Fixed protocol

Other: Standard protocol

Individualized

EXPERIMENTAL

Individualized protocol

Other: Individualized protocol

Control

SHAM COMPARATOR

Sham acupuncture/Placebo moxa

Other: Sham acupuncture/Placebo moxa

Interventions

Standard protocolOTHER

Subjects will receive a standard treatment

Standard
Individualized protocolOTHER

Subjects will receive an individualized treatment

Individualized
Sham acupuncture/Placebo moxaOTHER

Subjects will receive sham acupuncture/placebo moxa

Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Division of Special Studies in Symptom Management

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

AIEOP acute lymphoblastic leukemia protocol

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Joyce K Anastasi, PhD

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2014

First Posted

March 6, 2014

Study Start

November 1, 2012

Primary Completion

November 1, 2019

Study Completion

November 1, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Locations

US(1)