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CompletedNCT00752154Updated Sep 29, 2023

Curcumin in Rheumatoid Arthritis

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

Phase
Early Phase 1
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • Subjects
  • active
  • Rheumatoid
  • Arthritis
  • revised
  • American
  • College
  • Rheumatology
  • Criteria
03

In context

Arthritis

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age ≥ 18 years; read and understand English
  2. Stable dose of non-steroidal anti-inflammatory agents (NSAID) for ≥ 2 weeks.
  3. Oral prednisone or equivalent ≤ 10 mg daily and stable dose for ≥ 2 weeks(and must be kept stable throughout the duration of the protocol).

    • ESR > 20 mm/hr, or CRP > 0.8 mg/dl
  4. 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,
  5. Subjects must be diagnosed with rheumatoid arthritis based on the revised American College of Rheumatology criteria:Presence of > swollen and > 6 tender joint count (28 joint count), and either ESR > 20 mm/hr or CRP > 0.8 mg/dl

Exclusion criteria

Exclusion Criteria:

  1. Acute medical conditions deemed as inappropriate by the investigators (acute heart failure, uncontrolled diabetes mellitus, uncontrolled hypertension)
  2. AST/ALT > 1.5 upper limit of normal (ULN)
  3. Serum creatinine > 1.6 mg/dl
  4. Hemoglobin/Hematocrit \< 10.0 gram/dl/ 30.0
  5. Platelet count \< 100,000
  6. Current use of warfarin (as there is a drug interaction between curcumin and warfarin).
  7. Currently on biologic therapy (must have stopped etanercept for ≥ 4 weeks or adalimumab or infliximab for ≥ 8 weeks at time of Time 1 visit),
  8. Women who are pregnant,
  9. Subjects who are taking digoxin, warfarin and/or heparin,
  10. Subjects with a history of antiphospholipid syndrome and other thrombophilic states,
  11. Subjects who have an INR >= 1.5 at baseline,
  12. Subjects with acute episode(s) of cholecystitis within the last 6 months,
  13. Subjects with active peptic ulcer disease within the last 6 weeks
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Interventions

  • DrugCurcumin (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

06

What researchers measure

Primary outcomes

  1. American College of Rheumatology 20%

    Time frame: 4 month period

Secondary outcomes

  1. Inflammatory cell signaling markers

    Time frame: 4 month

  2. Safety of curcumin

    Time frame: 8 month

07

Study locations

2 sites
  • Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203
    Beverly Hills, California 90042, United States
  • UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor
    Los Angeles, California 90095, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00752154
Lead sponsor
University of California, Los Angeles
Responsible party
Sponsor
First posted
Sep 15, 2008
Start date
Jan 2010
Primary completion
Dec 1, 2010
Completion
Jan 1, 2011
Last update
Sep 29, 2023

Study contacts

Dinesh Khanna, M.D.
principal investigator · University of California, Los Angeles

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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