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

NCT ID: NCT01909037

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-31
• Study Completion Date: 2012-12-31

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flexofytol (bio-optimized curcumin)

Group Type: EXPERIMENTAL

Flexofytol (bio-optimized curcumin)

Intervention Type: DIETARY_SUPPLEMENT

2x3 caps/day (before breakfast and in the evening) for 3 months

Interventions

Flexofytol (bio-optimized curcumin)

2x3 caps/day (before breakfast and in the evening) for 3 months

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bioxtract SA

INDUSTRY

Sponsor Role: collaborator

Tilman S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Castermans, MD

Role: PRINCIPAL_INVESTIGATOR

Citadelle Hospital of Liege

Yvan Dierckxsens

Role: STUDY_DIRECTOR

Tilman S.A.

Locations

Citadelle Hospital

Liège, , Belgium

Countries

Belgium

References

Henrotin Y, Gharbi M, Dierckxsens Y, Priem F, Marty M, Seidel L, Albert A, Heuse E, Bonnet V, Castermans C. Decrease of a specific biomarker of collagen degradation in osteoarthritis, Coll2-1, by treatment with highly bioavailable curcumin during an exploratory clinical trial. BMC Complement Altern Med. 2014 May 17;14:159. doi: 10.1186/1472-6882-14-159.

Reference Type: DERIVED

PMID: 24886572 (View on PubMed)

Other Identifiers

TILFLEXFY 002

Identifier Type: -

Identifier Source: org_study_id