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CompletedNCT01909037Updated Jun 23, 2015

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

An Early Phase 1 interventional study of Flexofytol (bio-optimized curcumin) in Knee Osteoarthritis, sponsored by Tilman S.A.. Completed at 1 site in Belgium. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-06-23.

Sponsored by Tilman S.A. · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis

Keywords

  • osteoarthritis
  • curcumin
  • biomarker
  • pain
03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

This study's enrollment of 22 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Tilman S.A. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Flexofytol (bio-optimized curcumin)

    Dietary Supplement: Flexofytol (bio-optimized curcumin)

Interventions

  • Dietary supplementFlexofytol (bio-optimized curcumin)

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

06

What researchers measure

Primary outcomes

  1. Serum levels of biomarkers of cartilage metabolism and inflammation

    Change from baseline of serum levels of biomarkers

    Time frame: 84 days

Secondary outcomes

  1. 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

    Time frame: 84 days

07

Study locations

1 site
  • Citadelle Hospital
    Liege, 4000, Belgium
08

References and documents

Publications

  • 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. PubMed 24886572 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01909037
Lead sponsor
Tilman S.A.
Collaborators
Bioxtract SA
Responsible party
Sponsor
First posted
Jul 26, 2013
Start date
Mar 2012
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jun 23, 2015

Study contacts

Caroline Castermans, MD
principal investigator · Citadelle Hospital of Liege
Yvan Dierckxsens
study director · Tilman S.A.
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.

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