Status:
COMPLETED
Exploratory Non Comparative Study to Evaluate the Efficacy of Highly Bioavailable Curcumin (Flexofytol) in Patients With Knee Osteoarthritis
Lead Sponsor:
Tilman S.A.
Collaborating Sponsors:
Bioxtract SA
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
45-75 years
Phase:
EARLY_PHASE1
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 osteoar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01909037
Start Date
March 1 2012
End Date
December 1 2012
Last Update
June 23 2015
Active Locations (1)
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1
Citadelle Hospital
Liège, Belgium, 4000