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

Pain Clinical Trial

— Easykrill  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02318875
• Other study ID #: 2011-A00320-41/1
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2014
• Last updated: December 11, 2014
• Start date: June 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2014
• Source: Vivatech
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Muscular Diseases
• Pain

Intervention

Dietary Supplement:
• Kritech administration
300mg/day (1 capsule) during 12 weeks; oral ingestion

Other:
• Placebo adminstration
1 placebo capsule per day during 12 weeks; oral ingestion

Locations

Country	Name	City	State
France	Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
Vivatech

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SMFA score		12 weeks	Yes
Secondary	SMFA " dysfunction index " and " bother index " subscores		12 weeks	Yes
Secondary	MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire		12 weeks	Yes
Secondary	Pain evaluated by EVA (Échelle Visuelle Analogique)		12 weeks	Yes
Secondary	Clinical Global Impression (CGI scale)		12 weeks	Yes
Secondary	Analgesics consumption		12 weeks	Yes