Osteoarthritis, Knee
Conditions
Keywords
Osteoarthritis, Knee, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
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.
Interventions
DIETARY_SUPPLEMENTArantal® (highly bioavailable turmeric extract)
4 capsules a day, before breakfast
Sponsors
Nukleus
Bioxtract SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) | 15 days |
Secondary
| Measure | Time frame |
|---|---|
| Kinetics of the analgesic effect by a variance analysis in repeated measures (Likert Scale) | 15 days |
Countries
France
Outcome results
None listed