Turmeric for Patients With Basal Joint Arthritis
Primary Purpose
Thumb Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Turmeric
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thumb Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- 40 years of age or older
- English fluency and literacy
- Seeking care for basal joint pain
- Tender over basal joint
- Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
- Radiographic evidence of Eaton stage 1 and 2 only
Exclusion Criteria:
- Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
- Inability or unwillingness to participate in a trial study
- Rheumatoid Arthritis or other inflammatory disorder diagnoses
- Post-traumatic osteoarthritis
- Patients on Coumadin/Steroids/NSAIDs/Tylenol
- Diabetes Mellitus
- Pregnant or lactating women
- Basal joint arthritis of Eaton stage 3
- Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Turmeric
Control
Arm Description
Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
Outcomes
Primary Outcome Measures
Change in baseline pain intensity
0-10 ordinal rating of pain intensity
Change in baseline disability
Disability measured by the QuickDASH
Secondary Outcome Measures
Full Information
NCT ID
NCT03017118
First Posted
December 7, 2016
Last Updated
June 11, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03017118
Brief Title
Turmeric for Patients With Basal Joint Arthritis
Official Title
A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2017 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Turmeric
Arm Type
Experimental
Arm Description
Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Intervention Description
Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Subjects in the control group will receive a placebo 3 times per day for 6 weeks.
Primary Outcome Measure Information:
Title
Change in baseline pain intensity
Description
0-10 ordinal rating of pain intensity
Time Frame
Enrollment, 6 weeks, and 3 months
Title
Change in baseline disability
Description
Disability measured by the QuickDASH
Time Frame
Enrollment, 6 weeks, and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
40 years of age or older
English fluency and literacy
Seeking care for basal joint pain
Tender over basal joint
Positive distraction rotation test (rotation of the thumb metacarpal base while applying axial traction)
Radiographic evidence of Eaton stage 1 and 2 only
Exclusion Criteria:
Secondary gains (litigations or worker compensation) procedures that may interfere with patients' motivation for treatment
Inability or unwillingness to participate in a trial study
Rheumatoid Arthritis or other inflammatory disorder diagnoses
Post-traumatic osteoarthritis
Patients on Coumadin/Steroids/NSAIDs/Tylenol
Diabetes Mellitus
Pregnant or lactating women
Basal joint arthritis of Eaton stage 3
Patients seeking other treatment for their basal joint arthritis (splint, corticosteroid injection, surgery)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neal Chen, M.D.
Phone
617-726-4700
Email
nchen1@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Karan Amin, BA
Email
kamin2@mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Chen, MD
Phone
617-726-4700
Email
nchen1@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Kiera Lunn, BSc
Phone
6177261569
Email
klunn@mgh.harvard.edu
12. IPD Sharing Statement
Learn more about this trial
Turmeric for Patients With Basal Joint Arthritis
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