Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT03017118
Status:
RECRUITING
Last Update Posted:
2025-11-24
First Post:
2016-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Turmeric for Patients With Basal Joint Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-08-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2016-12-07', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in baseline pain intensity', 'timeFrame': 'Enrollment, 6 weeks, and 3 months', 'description': '0-10 ordinal rating of pain intensity'}, {'measure': 'Change in baseline disability', 'timeFrame': 'Enrollment, 6 weeks, and 3 months', 'description': 'Disability measured by the QuickDASH'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thumb Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to assess whether the use of a commercially available nutraceutical, turmeric, is an effective option to manage pain and stiffness in patients with basal joint arthritis. To conduct a pilot Randomized Controlled Trial evaluating the impact of turmeric on basal joint arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 40 years of age or older\n* English fluency and literacy\n* Seeking care for basal joint pain\n* Tender over basal joint\n* Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)\n* Radiographic evidence of Eaton stage 1 and 2 only\n\nExclusion Criteria:\n\n* Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment\n* Inability or unwillingness to participate in a trial study\n* Rheumatoid Arthritis or other inflammatory disorder diagnoses\n* Post-traumatic osteoarthritis\n* Patients on Coumadin/Steroids/NSAIDs/Tylenol\n* Diabetes Mellitus\n* Pregnant or lactating women\n* Basal joint arthritis of Eaton stage 3\n* Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)"}, 'identificationModule': {'nctId': 'NCT03017118', 'briefTitle': 'Turmeric for Patients With Basal Joint Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis', 'orgStudyIdInfo': {'id': '2016P001402'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Turmeric', 'description': 'Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.', 'interventionNames': ['Dietary Supplement: Turmeric']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Turmeric', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.', 'armGroupLabels': ['Turmeric']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subjects in the control group will receive a placebo 3 times per day for 6 weeks.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Neal Chen, MD', 'role': 'CONTACT', 'email': 'nchen1@mgh.harvard.edu', 'phone': '617-726-4700'}, {'name': 'Kiera Lunn, BSc', 'role': 'CONTACT', 'email': 'klunn@mgh.harvard.edu', 'phone': '6177261569'}], 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'centralContacts': [{'name': 'Neal Chen, M.D.', 'role': 'CONTACT', 'email': 'nchen1@mgh.harvard.edu', 'phone': '617-726-4700'}, {'name': 'Karan Amin, BA', 'role': 'CONTACT', 'email': 'kamin2@mgh.harvard.edu'}], 'overallOfficials': [{'name': 'Neal Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Neal Chung-Jen Chen', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}