Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis

Study Overview
=================
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.

Official Title
-----------------
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Dietary Supplement: Flexofytol (bio-optimized curcumin)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexofytol (bio-optimized curcumin)<br> | Dietary Supplement: Flexofytol (bio-optimized curcumin)<br>* 2x3 caps/day (before breakfast and in the evening) for 3 months<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of biomarkers of cartilage metabolism and inflammation | Change from baseline of serum levels of biomarkers | 84 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS) | Change from baseline of the mean pain over the last 24 hours and of the global assessment of disease activity by the patient | 84 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, curcumin, biomarker, pain