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

This study has been completed.
Information provided by:
Bioxtract SA
ClinicalTrials.gov Identifier:
First received: October 7, 2009
Last updated: May 6, 2010
Last verified: May 2010

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 Intervention Phase
Osteoarthritis, Knee
Dietary Supplement: Arantal® (highly bioavailable turmeric extract)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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).

Resource links provided by NLM:

Further study details as provided by Bioxtract SA:

Primary Outcome Measures:
  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) [ Time Frame: 15 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: June 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992004

Henri Mondor Hospital
Creteil, France, 94000
Sponsors and Collaborators
Bioxtract SA
Principal Investigator: Yves Henrotin, Pr University of Liege - Bone and Cartilage Research Unit
  More Information

No publications provided

Responsible Party: Dr Ingrid Jacquemond-Collet, bioXtract SA
ClinicalTrials.gov Identifier: NCT00992004     History of Changes
Other Study ID Numbers: ARKOS, 2009-A00174-53
Study First Received: October 7, 2009
Last Updated: May 6, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Bioxtract SA:
Osteoarthritis, Knee
Joint Diseases
Rheumatic Diseases

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Turmeric extract
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014