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

This study has been completed.
Sponsor:
Collaborators:
RDVC Produit de Santé.
Association Nationale de Prévention Médicale.
Information provided by (Responsible Party):
Lescuyer Laboratory
ClinicalTrials.gov Identifier:
NCT01356199
First received: May 17, 2011
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine whether the nutritional supplement ARTRONAT improves the quality of life of patients with osteoarthritis.


Condition Intervention
Osteoarthritis
Dietary Supplement: ARTRONAT
Dietary Supplement: PLACEBO

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Supportive Care
Official Title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques

Resource links provided by NLM:


Further study details as provided by Lescuyer Laboratory:

Primary Outcome Measures:
  • Reduction of gonalgia [ Time Frame: T8 months ] [ Designated as safety issue: No ]
    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. [ Time Frame: T2, T4, T6, T8 months ] [ Designated as safety issue: No ]
    Subjective global assessment measured on a 10-cm graduated scale (Visual Analogue Scale)


Enrollment: 7
Study Start Date: October 2011
Study Completion Date: December 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARTRONAT Dietary Supplement: ARTRONAT
Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.
Placebo Comparator: PLACEBO Dietary Supplement: PLACEBO
PLACEBO. 6 per day for 8 months.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356199

Locations
France
Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion
Treviou Treguignec, France, 22660
Sponsors and Collaborators
Lescuyer Laboratory
RDVC Produit de Santé.
Association Nationale de Prévention Médicale.
Investigators
Study Chair: Maurice Cloarec, MD Association Nationale de Prevention Medicale
Principal Investigator: Dominique Baron, MD Hospital Center of Lanion
  More Information

No publications provided

Responsible Party: Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01356199     History of Changes
Other Study ID Numbers: 2011-A00319-32
Study First Received: May 17, 2011
Last Updated: March 17, 2014
Health Authority: France: Committee for the Protection of Personnes
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Lescuyer Laboratory:
Gonalgia
Quality of Life
Dietary supplement
Nutrition

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014