Curcumin in Rheumatoid Arthritis
Recruitment status was Recruiting
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 40 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 4 grams per day.
Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study|
- American College of Rheumatology 20% [ Time Frame: 4 month period ] [ Designated as safety issue: No ]
- Inflammatory cell signaling markers [ Time Frame: 4 month ] [ Designated as safety issue: No ]
- Safety of curcumin [ Time Frame: 8 month ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Drug: Curcumin (Longvida™)
|Contact: Amber Bechtel, BSemail@example.com|
|Contact: Emma Hasan, Study Coordinatorfirstname.lastname@example.org|
|United States, California|
|Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203||Active, not recruiting|
|Beverly Hills, CA, California, United States, 90042|
|UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Amber Bechtel 310-825-0425 email@example.com|
|Contact: Emma Hasan, Study Coordinator 310-206-5732 firstname.lastname@example.org|
|Principal Investigator: Dinesh Khanna, M.D., MS|
|Principal Investigator:||Dinesh Khanna, M.D.||University of California, Los Angeles|