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Effect of Artronat on the Quality of Life of Patient With Osteoarthritis

Primary Purpose

Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ARTRONAT
PLACEBO
Sponsored by
Lescuyer Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Osteoarthritis focused on measuring Gonalgia, Quality of Life, Dietary supplement, Nutrition

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • age 40-75 years
  • BMI 18.5-30
  • osteoarthritis type II or III

Exclusion Criteria:

  • osteoarthritis type I or IV
  • allergy to one of the component of the supplement
  • blood pressure > 14/8
  • history of knee surgery

Sites / Locations

  • Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARTRONAT

PLACEBO

Arm Description

Outcomes

Primary Outcome Measures

Reduction of gonalgia
measure with the WOMAC.

Secondary Outcome Measures

Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.
Subjective global assessment measured on a 10-cm graduated scale (Visual Analogue Scale)

Full Information

First Posted
May 17, 2011
Last Updated
March 17, 2014
Sponsor
Lescuyer Laboratory
Collaborators
RDVC Produit de Santé., Association Nationale de Prévention Médicale.
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1. Study Identification

Unique Protocol Identification Number
NCT01356199
Brief Title
Effect of Artronat on the Quality of Life of Patient With Osteoarthritis
Official Title
Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lescuyer Laboratory
Collaborators
RDVC Produit de Santé., Association Nationale de Prévention Médicale.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.
Detailed Description
Osteoarthritis is a degenerative disease that greatly impairs the quality of life of patients. A nutritional supplement may help, in association with the normal treatment of osteoarthritis, improving the quality of life of such patients, in reducing pain and/or improving join flexibility.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Gonalgia, Quality of Life, Dietary supplement, Nutrition

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARTRONAT
Arm Type
Experimental
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
ARTRONAT
Intervention Description
Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
PLACEBO
Intervention Description
PLACEBO. 6 per day for 8 months.
Primary Outcome Measure Information:
Title
Reduction of gonalgia
Description
measure with the WOMAC.
Time Frame
T8 months
Secondary Outcome Measure Information:
Title
Evaluation of the satisfactory relief of symptoms of osteoarthritis at each visit after the beginning of supplementation, assessed by the patients.
Description
Subjective global assessment measured on a 10-cm graduated scale (Visual Analogue Scale)
Time Frame
T2, T4, T6, T8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 40-75 years BMI 18.5-30 osteoarthritis type II or III Exclusion Criteria: osteoarthritis type I or IV allergy to one of the component of the supplement blood pressure > 14/8 history of knee surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurice Cloarec, MD
Organizational Affiliation
Association Nationale de Prevention Medicale
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dominique Baron, MD
Organizational Affiliation
Hospital Center of Lanion
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion
City
Treviou Treguignec
ZIP/Postal Code
22660
Country
France

12. IPD Sharing Statement

Learn more about this trial

Effect of Artronat on the Quality of Life of Patient With Osteoarthritis

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