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

This study has been completed.
Sponsor:
Collaborator:
NuKleus
Information provided by:
Bioxtract SA
ClinicalTrials.gov Identifier:
NCT00992004
First received: October 7, 2009
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992004

Locations
France
Henri Mondor Hospital
Creteil, France, 94000
Sponsors and Collaborators
Bioxtract SA
NuKleus
Investigators
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
Osteoarthritis
Joint Diseases
Arthritis
Rheumatic Diseases

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

ClinicalTrials.gov processed this record on August 28, 2014