Full Text View
Tabular View
No Study Results Posted
Related Studies
Curcumin in Rheumatoid Arthritis
This study is currently recruiting participants.
Verified by University of California, Los Angeles, September 2008
First Received: September 11, 2008   Last Updated: September 16, 2008   History of Changes
Sponsored by: University of California, Los Angeles
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00752154
  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 20 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 12 grams per day.

Subjects will have blood tests, complete questionnaires, and be seen by the study doctor.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: curcumin
Phase 0

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
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:
  • Proportion of pats achieving ACR 20 Response Criteria & Change in the circulating levels of markers of inflammation, immune activation, and acute-phase reactants, in cellular levels of expression of TNF-alpha, IL6, and COX-2, and transcription factors [ Time Frame: at the end of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: curcumin
    Subjects will take either curcumin or placebo. The dosage will be increased every 2 wks for up to a total of 12 grams per day. Each beadlet is 4 grams. First wk - 1 beadlet once a day for 2 wks, 3rd wk - 2 beadlets once a day for 2 wks, 5th wk, 3 beadlets once a day which will be continued another 12 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 leflunoimide. 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 thromophilic 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752154

Contacts
Contact: Emma Hasan, Study Coordinator 310-206-5732 ehasan@mednet.ucla.edu
Contact: Sara Spencer, RN, MPH 310-206-4112 sspencer@mednet.ucla.edu

Locations
United States, California
UCLA, 1000 Veteran Avenue, Rehab Building, 3rd Floor Recruiting
Los Angeles, California, United States, 90095
Contact: Emma Hasan            
Contact: Sara Spencer            
Principal Investigator: Dinesh Khanna, M.D., MS            
Swamy Venuturpualli, M.D., 8737 Beverly Blvd., #203 Active, not recruiting
Beverly Hills, CA, California, United States, 90042
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: UCLA ( Dinesh Khanna, M.D., MS - Principal Investigator )
Study ID Numbers: 07-12-051
Study First Received: September 11, 2008
Last Updated: September 16, 2008
ClinicalTrials.gov Identifier: NCT00752154     History of Changes
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

Study placed in the following topic categories:
Anti-Inflammatory Agents
Autoimmune Diseases
Curcumin
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Musculoskeletal Diseases
Analgesics, Non-Narcotic
Arthritis
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents

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

ClinicalTrials.gov processed this record on September 02, 2009