Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2026-02-25 @ 9:20 PM
Study NCT ID:
NCT02079857
Status:
COMPLETED
Last Update Posted:
2020-07-28
First Post:
2014-03-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptom Management for Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077194', 'term': 'AIEOP acute lymphoblastic leukemia protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-27', 'studyFirstSubmitDate': '2014-03-03', 'studyFirstSubmitQcDate': '2014-03-04', 'lastUpdatePostDateStruct': {'date': '2020-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom severity-abdominal pain', 'timeFrame': 'week 1'}, {'measure': 'Symptom severity-abdominal pain', 'timeFrame': 'week 4'}, {'measure': 'Symptom severity-abdominal pain', 'timeFrame': 'week 8'}, {'measure': 'Symptom severity-abdominal pain', 'timeFrame': 'week 12'}, {'measure': 'Symptom severity-abdominal pain', 'timeFrame': 'week 24'}]}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women 18 to 70 years of age.\n* Diagnosis of IBS based on ROME III criteria.\n* Complete symptom diaries and return completed diaries at all sessions.\n\nExclusion Criteria:\n\n* History of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology.\n* Alarm symptoms according to ROME III.\n* Individuals currently receiving other types of complementary therapies.\n* Individuals with an acute medical condition requiring acute medical attention.'}, 'identificationModule': {'nctId': 'NCT02079857', 'briefTitle': 'Symptom Management for Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Symptom Management for Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': '12-02325'}, 'secondaryIdInfos': [{'id': 'R01NR013695', 'link': 'https://reporter.nih.gov/quickSearch/R01NR013695', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard', 'description': 'Fixed protocol', 'interventionNames': ['Other: Standard protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Individualized', 'description': 'Individualized protocol', 'interventionNames': ['Other: Individualized protocol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Sham acupuncture/Placebo moxa', 'interventionNames': ['Other: Sham acupuncture/Placebo moxa']}], 'interventions': [{'name': 'Standard protocol', 'type': 'OTHER', 'description': 'Subjects will receive a standard treatment', 'armGroupLabels': ['Standard']}, {'name': 'Individualized protocol', 'type': 'OTHER', 'description': 'Subjects will receive an individualized treatment', 'armGroupLabels': ['Individualized']}, {'name': 'Sham acupuncture/Placebo moxa', 'type': 'OTHER', 'description': 'Subjects will receive sham acupuncture/placebo moxa', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10010', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Division of Special Studies in Symptom Management', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Joyce K Anastasi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Nursing Research (NINR)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}