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Completed

NCT Number: NCT02318875

Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN

Bordeaux, 33076, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Kritech administration

Dietary Supplement

300mg/day (1 capsule) during 12 weeks; oral ingestion

Placebo adminstration

Other

1 placebo capsule per day during 12 weeks; oral ingestion

Primary outcomes

  1. SMFA score

    Time frame: 12 weeks

Secondary outcomes

  1. SMFA " dysfunction index " and " bother index " subscores

    Time frame: 12 weeks

  2. MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire

    Time frame: 12 weeks

  3. Pain evaluated by EVA (Échelle Visuelle Analogique)

    Time frame: 12 weeks

  4. Clinical Global Impression (CGI scale)

    Time frame: 12 weeks

  5. Analgesics consumption

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Vivatech

Industry

Registry information

Acronym: Easykrill

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 17, 2014
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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