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Sponsored by: |
University of California, Los Angeles |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00752154 |
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 turmeric. The study drug being tested in this study is curcumin.
This study is called a cross-over study because all subjects will receive the study drug for a certain amount of time and then switch to placebo (an inactive substance) for a certain time or vice versa. The subject's participation may last up to 8 months.
The subject will be randomized (by chance; like flipping a coin) to receive either the study drug, curcumin, or placebo for 4 months. After 4 months, if the subject was taking curcumin they will stop taking it and begin to take placebo and if the subject was taking placebo they will stop taking it and begin taking curcumin for the remaining 4 months. By completion of the study, all 20 subjects will have taken curcumin and placebo for 4 months each.
Curcumin/placebo will be provided in capsule form and the subject will take it by mouth. The dose dose will be increased every week for up to a total of 12 grams per day.
Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: curcumin |
Phase 0 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study |
Estimated Enrollment: | 20 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥2 weeks(and must be kept stable throughout the duration of the protocol).
Exclusion Criteria:
Contact: Emma Hasan, Study Coordinator | 310-206-5732 | ehasan@mednet.ucla.edu |
Contact: Sara Spencer, RN, MPH | 310-206-4112 | sspencer@mednet.ucla.edu |
United States, California | |
UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor | Recruiting |
Los Angeles, California, United States, 90095 | |
Contact: Emma Hasan | |
Contact: Sara Spencer | |
Principal Investigator: Dinesh Khanna, M.D., MS | |
Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203 | Active, not recruiting |
Beverly Hills, CA, California, United States, 90042 |
Principal Investigator: | Dinesh Khanna, M.D. | University of California, Los Angeles |
Responsible Party: | UCLA ( Dinesh Khanna, M.D., MS - Principal Investigator ) |
Study ID Numbers: | 07-12-051 |
Study First Received: | September 11, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00752154 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Subjects active Rheumatoid Arthritis revised |
American College Rheumatology Criteria |
Anti-Inflammatory Agents Autoimmune Diseases Curcumin Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Musculoskeletal Diseases |
Analgesics, Non-Narcotic Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents |
Anti-Inflammatory Agents Autoimmune Diseases Curcumin Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Joint Diseases Physiological Effects of Drugs Arthritis, Rheumatoid Enzyme Inhibitors Rheumatic Diseases Pharmacologic Actions |
Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |