Hydrolyzed Fish Cartilage Effect on Knee Joint Functionality and Discomfort in Adult Population

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Abyss Ingredients
Updated on 19 February 2024

Summary

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.

Details
Condition Knee Discomfort
Age 40-80 years
Treatment Cartidyss
Clinical Study IdentifierNCT04420091
SponsorAbyss Ingredients
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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