Status:
COMPLETED
Curcumin in Rheumatoid Arthritis
Lead Sponsor:
University of California, Los Angeles
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
Curcuma longa or turmeric is a tropical plant native to south and southeast tropical Asia. Perhaps the most active component in turmeric is curcumin which may make up 2-5% of the total spice in turmer...
Eligibility Criteria
Inclusion
- Age ≥ 18 years; read and understand English
- Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks.
- Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol).
- ESR \> 20 mm/hr, or CRP \> 0.8 mg/dl
- May be using any of the following DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or leflunomide. If using any of these DMARDs must be using them for ≥ 12 weeks and stable dose for ≥ 4 weeks. If using other DMARD, or DMARD combinations, these additional or other DMARDs must be stopped for ≥ 4 weeks before baseline visit. May also participate if patient not on DMARD,
- Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of \> swollen and \> 6 tender joint count (28 joint count), and either ESR \> 20 mm/hr or CRP \> 0.8 mg/dl
Exclusion
- Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
- AST/ALT \> 1.5 upper limit of normal (ULN)
- Serum creatinine \> 1.6 mg/dl
- Hemoglobin/Hematocrit \< 10.0 gram/dl/ 30.0
- Platelet count \< 100,000
- Current use of warfarin (as there is a drug interaction between curcumin and warfarin).
- Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit),
- Women who are pregnant,
- Subjects who are taking digoxin, warfarin and/or heparin,
- Subjects with a history of antiphospholipid syndrome and other thrombophilic states,
- Subjects who have an INR \>= 1.5 at baseline,
- Subjects with acute episode(s) of cholecystitis within the last 6 months,
- Subjects with active peptic ulcer disease within the last 6 weeks
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00752154
Start Date
January 1 2010
End Date
January 1 2011
Last Update
September 29 2023
Active Locations (2)
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1
Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
Beverly Hills, California, United States, 90042
2
UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor
Los Angeles, California, United States, 90095