Knee Osteoarthritis
Conditions
Keywords
osteoarthritis, curcumin, biomarker, pain
Brief summary
The purpose of this study is to evaluate the efficacy of bio-optimized curcumin(Flexofytol) during a 90-days period in knee ostearthritis patients on the serum levels of specific biomarkers of osteoarthritis and on the evaluation of pain.
Interventions
DIETARY_SUPPLEMENTFlexofytol (bio-optimized curcumin)
2x3 caps/day (before breakfast and in the evening) for 3 months
Sponsors
Bioxtract SA
Tilman S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 45 to 80 years of age * Internal femorotibial gonarthrosis responding to the clinical and radiological criteria of ACR * Symptomatic knee for more than 6 months * Mean knee pain on the last 24 hours of at least 40 mm on VAS * Kellgren & Laurence grade II to III * Patients able to avoid NSAIDs and analgesics during the study * Patients having signed informed consent * Patients able to follow the study instructions
Exclusion criteria
* Related to the osteoarthritis pathology: * Osteoarthritis linked to a metabolic arthropathy * Predominant associated symptomatic femoropatellar osteoarthritis * Chondromatosis or villonodular synovitis of the knee * Recent trauma (\< 1 month) of the knee responsible for the pain * Inflammatory flare * Pathology potentially interfering with the evaluation (metabolic inflammatory arthropathy, rheumatoid arthritis, lower limb radiculalgia, arthritis... * Paget disease * Homolateral coxarthrosis * Articular Prosthesis * Knee joint effusion * 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, * NSAID or analgesics in the 72 hours prior to inclusion * No modification of Slow-acting drugs for OA and/or dietary supplements taken within less than 6 months prior to the study(ex: chondroitin sulfate, diacerein, soy and avocado unsaponifiables, oxaceprol, granions de cuivre, glucosamine, phytotherapy for OA, homeopathy for OA...), * Anticoagulant (coumarinic) treatment and heparin * General corticotherapy, * Contraindication to paracetamol. * Related to associated pathologies: * Patient suffering from serious associated illness (liver failure, kidney failure, non-controlled cardiovascular diseases...) * 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 | Description |
|---|---|---|
| Serum levels of biomarkers of cartilage metabolism and inflammation | 84 days | Change from baseline of serum levels of biomarkers |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS) | 84 days | Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient |
Countries
Belgium
Outcome results
None listed