This study is an exploratory, non-comparative, multi-centric trial in 30 free-living healthy male and female subjects with moderate knee joint discomfort and loss of functionality. The objective of this trial is to determine whether oral administration of Cartidyss, a concentrated fish cartilage extract, can contribute to the improvement of knee joint functionality and discomfort in adult population
30 patients will be enrolled during a 4-month period in 3 investigational sites and each patient will undergo 3 visits (V0: Inclusion visit at baseline, V1: Follow-Up Visit after 1 month ± 3 day and V2: End Visit after 3 months ± 5 days). The primary objective of this trial is to determine whether oral administration of Cartidyss, a concentrated fish cartilage extract, can contribute to the improvement of knee joint functionality and discomfort in adult population, using a specific self-administered questionnaire. The secondary objectives of the study are to evaluate the effect of Cartidyss on knee function and pain at rest and while walking, with patient global assessment and quality of life at each time point. The tolerance, compliance, satisfaction, rate of responder to the supplementation and pain killer's consumption would be also evaluated as secondary endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
32
Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months
Centre medical Chant d'Oiseau
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, Belgium
Hopital Princesse Paola, VIVALIA
Marche-en-Famenne, Belgium
Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation
Changes from baseline to 3 months of Knee injury and Osteoarthritis Outcome Score (KOOS) global score using a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
Time frame: 3 months (Day 0, Month 1 and Month 3)
Evaluate the effect of Cartidyss on knee function after 3 months of supplementation
Changes from baseline to each time points of knee function using the KOOS questionnaire, a specific self-administered questionnaire Variation of Knee injury and Osteoarthritis Outcome Score. The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
Time frame: 3 months (Day 0, Month 1 and Month 3)
Evaluate the effect of Cartidyss on knee pain at rest and while walking after 3 months of supplementation
Changes from baseline to each time points. Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by 2 verbal descriptors, one for each symptom extreme.
Time frame: 3 months (Day 0, Month 1 and Month 3)
Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation
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Changes from baseline to each time points. Variation of Visual Analogue Scale for patient global assessment of disease activity The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length (0-100mm), anchored by one verbal descriptors for Global Assessment of disease activity.
Time frame: 3 months (Day 0, Month 1 and Month 3)
Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation
Changes from baseline to each time points. A global score will be calculated in function of the answers of a Self-administered questionnaire (SF-36). The SF-36 is a 36-item patient-reported questionnaire that covers eight health domains: physical functioning (10 items), bodily pain (2 items), role limitations due to physical health problems (4 items), role limitations due to personal or emotional problems (4 items), emotional well-being (5 items), social functioning (2 items), energy/fatigue (4 items), and general health perceptions (5 items). Scores for each domain range from 0 to 100, with a higher score defining a more favorable health state.
Time frame: 3 months (Day 0, Month 1 and Month 3)
Evaluate the tolerance of Cartidyss after 3 months of supplementation
Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of System Organ Class (SOC) and Low Level Terms (LLT) using the last version of MedDRA) and drop offs
Time frame: Only Month 1 and Month 3
Evaluate the compliance of Cartidyss after 3 months of supplementation
Count the capsules in investigation kits brought back by the patient.
Time frame: Only Month 1 and Month 3
Evaluate the satisfaction of Cartidyss after 3 months of supplementation
Changes after supplementation. Self-administered questionnaire using a 5-Likert scale (extremely unsatisfied- unsatisfied- nor unsatisfied nor satisfied- satisfied- extremely satisfied) to evaluate the product.
Time frame: Only Month 1 and Month 3
Evaluate the pain killer's consumption during the 3 months of supplementation
Changes after supplementation. Count the number of consumed pain killer
Time frame: Only Month 1 and Month 3
Evaluate the rate of responder to the 3 months supplementation of Cartidyss
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to the Outcome Measures in Rheumatology (OMERACT) and the OsteoArthritis Research Society International (OARSI) criteria. Responder criteria for osteoarthritis clinical trials based on the questionnaires describe above.
Time frame: Only Month 1 and Month 3