Last updated: September 27, 2023
Sponsor: University of California, Los Angeles
Overall Status: Completed
Phase
1
Condition
Joint Injuries
Dermatomyositis (Connective Tissue Disease)
Rheumatoid Arthritis
Treatment
Curcumin (Longvida™)
Clinical Study ID
NCT00752154
07-12-051
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 bekept 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 AmericanCollege of Rheumatology criteria:Presence of > swollen and > 6 tender joint count (28joint count), and either ESR > 20 mm/hr or CRP > 0.8 mg/dl
Exclusion
Exclusion Criteria:
- Acute medical conditions deemed as inappropriate by the investigators (acute heartfailure, 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 andwarfarin).
- Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks oradalimumab 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
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Curcumin (Longvida™)
Phase: 1
Study Start date:
January 01, 2010
Estimated Completion Date:
January 01, 2011
Connect with a study center
Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
Beverly Hills, California 90042
United StatesSite Not Available
Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
Beverly Hills, CA, California 90042
United StatesSite Not Available
UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor
Los Angeles, California 90095
United StatesSite Not Available

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