Effect of Cartidyss-based Dietary Supplement on Knee Joint Functionality and Discomfort in Adult Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Cartidyss
干预措施: Cartidyss (Dietary Supplement)
结局指标
主要结局
Evaluate the effect of Cartidyss on knee functionality and discomfort after 3 months of supplementation
时间窗: 3 months (Day 0, Month 1 and Month 3)
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.
次要结局
- Evaluate the effect of Cartidyss on knee function after 3 months of supplementation(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(3 months (Day 0, Month 1 and Month 3))
- Evaluate the effect of Cartidyss on patient global assessment after 3 months of supplementation(3 months (Day 0, Month 1 and Month 3))
- Evaluate the effect of Cartidyss on quality of life after 3 months of supplementation(3 months (Day 0, Month 1 and Month 3))
- Evaluate the tolerance of Cartidyss after 3 months of supplementation(Only Month 1 and Month 3)
- Evaluate the compliance of Cartidyss after 3 months of supplementation(Only Month 1 and Month 3)
- Evaluate the satisfaction of Cartidyss after 3 months of supplementation(Only Month 1 and Month 3)
- Evaluate the pain killer's consumption during the 3 months of supplementation(Only Month 1 and Month 3)
- Evaluate the rate of responder to the 3 months supplementation of Cartidyss(Only Month 1 and Month 3)