An Early Phase 1 interventional study of Curcumin (Longvida™) in Rheumatoid Arthritis, sponsored by University of California, Los Angeles. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-29.
Sponsored by University of California, Los Angeles · Early Phase 1, Interventional, and Treatment
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 40 is below the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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
This study is completed, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.
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University of California, Los Angeles