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

March 17, 2014 updated by: Lescuyer Laboratory

Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Treviou Treguignec, France, 22660
        • Centre Rééducation et Réadaptation Fonctionnelles de Trestel , Centre Hospitalier Pierre-Le-Damany Lannion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: PLACEBO
Dietary supplement: PLACEBO
PLACEBO. 6 per day for 8 months.
Experimental: ARTRONAT
Dietary supplement: ARTRONAT
Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of gonalgia
Time Frame: T8 months
measure with the WOMAC.
T8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
T2, T4, T6, T8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lescuyer Laboratory

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

May 17, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2014

Last Update Submitted That Met QC Criteria

March 17, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A00319-32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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