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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356199
First Posted: May 19, 2011
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
RDVC Produit de Santé.
Association Nationale de Prévention Médicale.
Information provided by (Responsible Party):
Lescuyer Laboratory
  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
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Lescuyer Laboratory
ClinicalTrials.gov Identifier: NCT01356199     History of Changes
Other Study ID Numbers: 2011-A00319-32
First Submitted: May 17, 2011
First Posted: May 19, 2011
Last Update Posted: March 18, 2014
Last Verified: March 2014

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

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