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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01909037
• Other study ID #: TILFLEXFY 002
• Status: Completed
• Phase: Phase 0
• First received: July 18, 2013
• Last updated: June 22, 2015
• Start date: March 2012
• Est. completion date: December 2012

Study information

• Verified date: July 2013
• Source: Tilman S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics CommitteeBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Dietary Supplement:
• Flexofytol (bio-optimized curcumin)
2x3 caps/day (before breakfast and in the evening) for 3 months

Locations

Country	Name	City	State
Belgium	Citadelle Hospital	Liege

Sponsors (2)

Lead Sponsor	Collaborator
Tilman S.A.	Bioxtract SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum levels of biomarkers of cartilage metabolism and inflammation	Change from baseline of serum levels of biomarkers	84 days	No
Secondary	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	No