Curcumin in Rheumatoid Arthritis
|ClinicalTrials.gov Identifier: NCT00752154|
Recruitment Status : Unknown
Verified September 2008 by University of California, Los Angeles.
Recruitment status was: Recruiting
First Posted : September 15, 2008
Last Update Posted : July 2, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Curcumin (Longvida™)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||January 2011|
- Drug: Curcumin (Longvida™)
Curcumin (Longvida™) or matching placebo. They will begin by taking 4 capsules (approximately 2 grams) once a day for 2 weeks and then the dose will be increased to 4 capsules twice a day (4 gram per day) beginning at week 3. Subjects will remain at this dose for an additional 13 weeks for a total 16 weeks. After 16 weeks, the same procedures will be repeated for another 16 weeks
- American College of Rheumatology 20% [ Time Frame: 4 month period ]
- Inflammatory cell signaling markers [ Time Frame: 4 month ]
- Safety of curcumin [ Time Frame: 8 month ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00752154
|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|