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Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).

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ClinicalTrials.gov Identifier: NCT00992004
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : May 7, 2010
Sponsor:
Collaborator:
Nukleus
Information provided by:
Bioxtract SA

Tracking Information
First Submitted Date  ICMJE October 7, 2009
First Posted Date  ICMJE October 8, 2009
Last Update Posted Date May 7, 2010
Study Start Date  ICMJE June 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 7, 2009)
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 8, 2009)
Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2009)
Kinetics of the antalgic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Official Title  ICMJE Comparative, Randomized, Double-blind, Placebo-controlled, Parallel Group Study, to Evaluate the Efficacy of a Turmeric Extract (Arantal®) Versus Placebo in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Brief Summary The purpose of this study is to determine the efficacy and the tolerance on 15 days of a turmeric extract (Arantal®) on pain related to gonarthrosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis, Knee
Intervention  ICMJE Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
4 capsules a day, before breakfast
Study Arms  ICMJE
  • Experimental: Arantal®
    Highly bioavailable turmeric extract (food supplement)
    Intervention: Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
  • Placebo Comparator: Placebo
    Same capsule without the active ingredients (only excipients)
    Intervention: Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
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 Completed
Estimated Enrollment  ICMJE
 (submitted: October 7, 2009)
280
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is 40 through 80 years of age
  • Subject diagnosed with femorotibial osteoarthritis of the knee (diagnosed according to the clinical and radiologic criteria of ACR),
  • Patient's Assessment of Arthritis Pain measurement on the last 24 hours of at least 50 mm on VAS,
  • Patient has not received any NSAIDs within 72 hours and any analgesics within 24 hours,
  • Patients with chronic knee pain (i.e., knee pain at least every other day during the month preceding inclusion),
  • Patients with radiologic knee osteoarthritis (Kellgren-Lawrence grade 2-4, on radiography less than 12 months old),
  • Patients having signed the informed consent,
  • Patients capable of comprehend the study instructions.

Exclusion Criteria:

  • Related to the osteoarthritis pathology:

    • Osteoarthritis linked to a metabolic arthropathy: chondrocalcinosis already diagnosed or defined by calcium edging on at least one femorotibial joint space, gout...,
    • Predominant associated symptomatic femoropatellar osteoarthritis,
    • Chondromatosis or villonodular synovitis of the knee,
    • Recent trauma (< 1 month) of the knee responsible for the pain,
    • Knee joint effusion justifying an evacuation through puncturing,
    • Inflammatory flare (night pain, joint effusion) corresponding to a KOFUS score less than 7,
    • Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis...),
  • Related to previous and associated treatments:

    • Corticosteroids injection in the previous month, whatever the joint concerned,
    • Hyaluronan injection in the evaluated knee during the previous 6 months,
    • Patient who took NSAID in the 72 hours prior to inclusion or Analgesics in the 24 hours prior to inclusion,
    • Slow-acting drugs for OA and/or dietary supplements taken within less than 3 months prior to the study product administration or for which the dose has been modified in the last three months (ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...),
    • Anticoagulant treatment without gastric protection,
    • General corticotherapy,
    • Contraindication to paracetamol.
  • Related to associated pathologies:

    • Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...),
    • Peptic ulcer.
  • Related to patients:

    • Pregnant or breastfeeding women
    • Pre-menopausal women with no contraception
    • Patients unable to write
    • Patients enrolled in a clinical trial in the previous 3 months
    • Patients under juristic protection or under guardianship.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 80 Years   (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 France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00992004
Other Study ID Numbers  ICMJE ARKOS
2009-A00174-53
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Ingrid Jacquemond-Collet, bioXtract SA
Study Sponsor  ICMJE Bioxtract SA
Collaborators  ICMJE Nukleus
Investigators  ICMJE
Principal Investigator: Yves Henrotin, Pr University of Liege - Bone and Cartilage Research Unit
PRS Account Bioxtract SA
Verification Date May 2010

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