Turmeric for Patients With Basal Joint Arthritis
A Randomized Controlled Trial Using Turmeric for Patients With Basal Joint Arthritis
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Neal Chen, M.D.
- Phone Number: 617-726-4700
- Email: nchen1@mgh.harvard.edu
Study Contact Backup
- Name: Karan Amin, BA
- Email: kamin2@mgh.harvard.edu
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Recruiting
- Massachusetts General Hospital
-
Contact:
- Kiera Lunn, BSc
- Phone Number: 6177261569
- Email: klunn@mgh.harvard.edu
-
Contact:
- Neal Chen, MD
- Phone Number: 617-726-4700
- Email: nchen1@mgh.harvard.edu
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Turmeric
Subjects in this group will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
|
Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
|
|
Placebo Comparator: Control
Subjects in this group will receive a placebo pill 3 times per day for 6 weeks.
|
Subjects in the control group will receive a placebo 3 times per day for 6 weeks.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in baseline pain intensity
Time Frame: Enrollment, 6 weeks, and 3 months
|
0-10 ordinal rating of pain intensity
|
Enrollment, 6 weeks, and 3 months
|
|
Change in baseline disability
Time Frame: Enrollment, 6 weeks, and 3 months
|
Disability measured by the QuickDASH
|
Enrollment, 6 weeks, and 3 months
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Neal Chen, MD, Massachusetts General Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Estimated)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2016P001402
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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