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

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Kritech administration
Placebo adminstration
Sponsored by
Vivatech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain focused on measuring Inflammation, swell, pain, functional impairment, stiffness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Kritech group

Placebo group

Arm Description

Subjects take 1 Kritech capsule per day (dose of 300mg)

Subjects take 1 placebo capsule per day

Outcomes

Primary Outcome Measures

SMFA score

Secondary Outcome Measures

SMFA " dysfunction index " and " bother index " subscores
MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire
Pain evaluated by EVA (Échelle Visuelle Analogique)
Clinical Global Impression (CGI scale)
Analgesics consumption

Full Information

First Posted
December 8, 2014
Last Updated
December 11, 2014
Sponsor
Vivatech
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1. Study Identification

Unique Protocol Identification Number
NCT02318875
Brief Title
Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders
Acronym
Easykrill
Official Title
Investigation of Kritech Efficacy on Subjects Having Functional Discomfort Associated to Joints and Muscles Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vivatech

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Inflammation, swell, pain, functional impairment, stiffness

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kritech group
Arm Type
Experimental
Arm Description
Subjects take 1 Kritech capsule per day (dose of 300mg)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Subjects take 1 placebo capsule per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Kritech administration
Intervention Description
300mg/day (1 capsule) during 12 weeks; oral ingestion
Intervention Type
Other
Intervention Name(s)
Placebo adminstration
Intervention Description
1 placebo capsule per day during 12 weeks; oral ingestion
Primary Outcome Measure Information:
Title
SMFA score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SMFA " dysfunction index " and " bother index " subscores
Time Frame
12 weeks
Title
MCS (Mental Composite Score) and PCS (Physical Composite Score) of SF-36® questionnaire
Time Frame
12 weeks
Title
Pain evaluated by EVA (Échelle Visuelle Analogique)
Time Frame
12 weeks
Title
Clinical Global Impression (CGI scale)
Time Frame
12 weeks
Title
Analgesics consumption
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicholas Moore, Professor
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Plateforme de Recherche Clinique - CIC1401- Plurithématique Tripode 13A3 Hôpital PELLEGRIN
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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

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