Curcumin in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 9 October 2023
• Main ID: NCT00752154
• Date of registration: 11/09/2008
• Prospective Registration: Yes
• Primary sponsor: University of California, Los Angeles
• Public title: Curcumin in Rheumatoid Arthritis
• Scientific title: Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study
• Date of first enrolment: January 2010
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT00752154
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Dinesh Khanna, M.D.
• Affiliation: University of California, Los Angeles

Key inclusion & exclusion criteria

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:

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Curcumin (Longvida™)

Primary Outcome(s)

American College of Rheumatology 20% [Time Frame: 4 month period]

Secondary Outcome(s)

Safety of curcumin [Time Frame: 8 month]

Inflammatory cell signaling markers [Time Frame: 4 month]

Secondary ID(s)

07-12-051

Source(s) of Monetary Support

Please refer to primary and secondary sponsors