Overview
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
Description
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.
Eligibility
Inclusion Criteria:
- Male or female
- Age limits (see above)
- Body Mass Index BMI 35 kg/m2
- Knee discomfort score at rest over the last 24 hours on the most painful knee evaluated on VAS (0-100) 40 at baseline
- Able to follow the instructions of the study
- Having signed an informed consent
Exclusion Criteria:
- related to knee:
- Recent trauma (< 1 month) of the knee responsible of the symptomatic knee;
- Concurrent articular disease interfering with the evaluation of knee pain left to the Investigator's discretion
- Prosthesis in the target knee
- related to treatments:
- Analgesics to manage knee pain 24 hours before inclusion visit;
- Corticosteroids injection in the target knee in the last month;
- Hyaluronan injection in the target knee in the last 6 months;
- Arthroscopy in the last 6 months
- Oral corticotherapy 5mg/day (in Prednisolone equivalent) in the last 3 months;
- Symptomatic slow-acting drugs for osteoarthritis (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine, diacerein or avocado-soya unsaponifiables int he last 3 months
- Contraindications to Cartidyss: hypersensitivity or allergy to the product components (fish)
- Treatments based on strontium ranelate, bisphosphonates, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months
- related to associated diseases :
- Any severe, uncontrolled and limiting diseases left to the Investigator's discretion
- Anticipated need for any surgical or other invasive procedure during the trial including prosthesis in the target knee
- Anticipated need for any forbidden treatments during the trial
- Swallowing disorder
- Patient with widespread pain/depression (e.g. fibromyalgia)
- related to patients:
- Close collaborators to the investigational team, the study coordinator or to the Sponsor
- Currently participating or having participated in another therapeutic clinical trial in the last 3 months
- Under guardianship or judicial protection
- Pregnancy, breastfeeding, planned conception, or premenopausal women without effective contraception (pill, patch, ring, diaphragm, implant and intrauterine device), tubal ligation or hysterectomy