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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 19, 2014