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NCT Number: NCT01909037

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

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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Citadelle Hospital

Liège, 4000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flexofytol (bio-optimized curcumin)

Dietary Supplement

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

Primary outcomes

  1. Serum levels of biomarkers of cartilage metabolism and inflammation

    Time frame: 84 days

    Change from baseline of serum levels of biomarkers

Secondary outcomes

  1. Pain and the global patient assessment of disease activity using a Visual Analog Scale (VAS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tilman S.A.

Industry

Collaborators

  • Bioxtract SA

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 26, 2013
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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