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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992004
Recruitment Status : Completed
First Posted : October 8, 2009
Last Update Posted : May 7, 2010
Information provided by:
Bioxtract SA

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Dietary Supplement: Arantal® (highly bioavailable turmeric extract) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Arantal®
Highly bioavailable turmeric extract (food supplement)
Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
4 capsules a day, before breakfast

Placebo Comparator: Placebo
Same capsule without the active ingredients (only excipients)
Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
4 capsules a day, before breakfast

Primary Outcome Measures :
  1. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ]

Secondary Outcome Measures :
  1. Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992004

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Henri Mondor Hospital
Creteil, France, 94000
Sponsors and Collaborators
Bioxtract SA
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Principal Investigator: Yves Henrotin, Pr University of Liege - Bone and Cartilage Research Unit
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Responsible Party: Dr Ingrid Jacquemond-Collet, bioXtract SA Identifier: NCT00992004    
Other Study ID Numbers: ARKOS
First Posted: October 8, 2009    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010
Keywords provided by Bioxtract SA:
Osteoarthritis, Knee
Joint Diseases
Rheumatic Diseases
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Turmeric extract
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs