Status:
COMPLETED
Evaluation of the Efficacy of a Turmeric Extract (Arantal®) in Patients With Osteoarthritis of the Knee (Gonarthrosis).
Lead Sponsor:
Bioxtract SA
Collaborating Sponsors:
Nukleus
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00992004
Start Date
June 1 2009
End Date
May 1 2010
Last Update
May 7 2010
Active Locations (1)
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1
Henri Mondor Hospital
Créteil, France, 94000