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

NCT ID: NCT01356199

Last Updated: 2014-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ARTRONAT

Group Type EXPERIMENTAL

ARTRONAT

Intervention Type DIETARY_SUPPLEMENT

Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.

PLACEBO

Group Type PLACEBO_COMPARATOR

PLACEBO

Intervention Type DIETARY_SUPPLEMENT

PLACEBO. 6 per day for 8 months.

Interventions

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ARTRONAT

Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.

Intervention Type DIETARY_SUPPLEMENT

PLACEBO

PLACEBO. 6 per day for 8 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RDVC Produit de Santé.

UNKNOWN

Sponsor Role collaborator

Association Nationale de Prévention Médicale.

UNKNOWN

Sponsor Role collaborator

Lescuyer Laboratory

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maurice Cloarec, MD

Role: STUDY_CHAIR

Association Nationale de Prevention Medicale

Dominique Baron, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Center of Lanion

Locations

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

Treviou Treguignec, , France

Site Status

Countries

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France

Other Identifiers

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2011-A00319-32

Identifier Type: -

Identifier Source: org_study_id

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