Curcumin in Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00752154
First received: September 11, 2008
Last updated: July 1, 2010
Last verified: September 2008
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: Curcumin (Longvida™)
Phase 0

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • American College of Rheumatology 20% [ Time Frame: 4 month period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00752154

Contacts
Contact: Amber Bechtel, BS 310-825-0425 abechtel@mednet.ucla.edu
Contact: Emma Hasan, Study Coordinator 310-206-5732 hasan@mednet.ucla.edu

Locations
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    abechtel@mednet.ucla.edu   
Contact: Emma Hasan, Study Coordinator    310-206-5732    ehasan@mednet.ucla.edu   
Principal Investigator: Dinesh Khanna, M.D., MS         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Dinesh Khanna, M.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Dinesh Khanna, M.D., MS - Principal Investigator, UCLA
ClinicalTrials.gov Identifier: NCT00752154     History of Changes
Other Study ID Numbers: 07-12-051
Study First Received: September 11, 2008
Last Updated: July 1, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
Subjects
active
Rheumatoid
Arthritis
revised
American
College
Rheumatology
Criteria

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 09, 2014