Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Vivatech
- 入组人数
- 154
- 试验地点
- 2
- 主要终点
- SMFA score
研究概览
简要总结
Joints and muscles disorders are common symptoms in the population. They are characterized by swelling, pain, functional impairment and morning stiffness. These disorders can be really disabling and painful, affecting the person's quality life. The purpose of this clinical trial is to test Kritech (Krill oil) efficacy in reducing these symptoms in 154 subjects complaining functional discomfort associated to joints and muscles disorders.
详细描述
Epidemiological studies on prevalence and incidence of joints and muscles disorders are scares. Two epidemiological French studies recorded patients consulting their GP for widespread pain, whatever the cause. The most often cited pain localization was the musculoskeletal system (36-59% of the cases). In Europe the situation is similar, with arthritis and osteoarthritis representing the 42% of pains. According to the WHO (World Health Organization) the musculoskeletal system's disorders are the first cause of handicap in the worldwide population.
Krill oil is low in both saturated fatty acids and monounsaturated fatty acid and high in polyunsaturated fatty acid including a high proportion of (n-3) fatty acids and particularly EPA and DHA. There are strong evidences that krill oil may improve the comfort of sensitive joints thank to its n-3 fatty acids and phospholipids content. Particularly, after a supplementation with a dietary product containing pure krill oil, a reduction of systemic inflammation, trough reduction of CRP, was concomitantly accompanied by improvement of various clinical scores associated with joint flexibility, comfort and function. Despite this, there are no studies yet on healthy volunteers complaining the symptoms of rheumatologic pathologies, without being ill.
Here we performed a clinical trial on 154 subjects complaining functional discomfort associated to joints and muscles disorders. The principal objective was to test Kritech efficacy in reducing these symptoms.
Subjects were split in two groups, with one receiving Kritech and the second one the placebo for 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects;
- •>18 years old;
- •Complaining functional discomfort associated to joints and/or muscles disorders, motility disorders and/or initial SMFA score higher or equal to 15 ;
- •Able to give a written or verbal informed consent,
- •Affiliated or beneficiary of social security
排除标准
- •IMC>30kg/m
- •Acute or chronic, progressive joint disorders (arthrosis, rheumatoid arthritis, acute articular rheumatism) of first or second degree and correlated treatments;
- •Subjects refusing of giving their written or verbal informed consent
- •Subjects deprived of freedom following an administrative or judicial decision
- •Participation to another clinical trial in the last four weeks;
- •People who already participated to another research that comprises an exclusion period still ongoing at the time of inclusion
结局指标
主要结局
SMFA score
时间窗: 12 weeks
次要结局
- Analgesics consumption(12 weeks)
- SMFA " dysfunction index " and " bother index " subscores(12 weeks)
- MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire(12 weeks)
- Pain evaluated by EVA (Échelle Visuelle Analogique)(12 weeks)
- Clinical Global Impression (CGI scale)(12 weeks)