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Trial record 61 of 167 for:    curcumin

Curcumin in Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT00752154
Recruitment Status : Unknown
Verified September 2008 by University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : September 15, 2008
Last Update Posted : July 2, 2010
Sponsor:
Information provided by:
University of California, Los Angeles

Tracking Information
First Submitted Date  ICMJE September 11, 2008
First Posted Date  ICMJE September 15, 2008
Last Update Posted Date July 2, 2010
Study Start Date  ICMJE January 2010
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
American College of Rheumatology 20% [ Time Frame: 4 month period ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2008)
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 ]
Change History Complete list of historical versions of study NCT00752154 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 2, 2010)
  • Inflammatory cell signaling markers [ Time Frame: 4 month ]
  • Safety of curcumin [ Time Frame: 8 month ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Curcumin in Rheumatoid Arthritis
Official Title  ICMJE Curcumin in Rheumatoid Arthritis - ACross-Over Pilot Study
Brief 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 2, 2010)
40
Original Estimated Enrollment  ICMJE
 (submitted: September 12, 2008)
20
Estimated Study Completion Date  ICMJE January 2011
Estimated Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00752154
Other Study ID Numbers  ICMJE 07-12-051
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dinesh Khanna, M.D., MS - Principal Investigator, UCLA
Study Sponsor  ICMJE University of California, Los Angeles
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dinesh Khanna, M.D. University of California, Los Angeles
PRS Account University of California, Los Angeles
Verification Date September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP