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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01356199
Date of registration: 17/05/2011
Prospective Registration: Yes
Primary sponsor: Lescuyer Laboratory
Public title: Effect of Artronat on the Quality of Life of Patient With Osteoarthritis
Scientific title: Effet du complément Alimentaire ARTRONAT(R) Sur la réduction de la Gonalgie Chez Des Sujets Arthrosiques
Date of first enrolment: October 2011
Target sample size: 7
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01356199
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  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Dominique Baron, MD
Address: 
Telephone:
Email:
Affiliation:  Hospital Center of Lanion
Name:     Maurice Cloarec, MD
Address: 
Telephone:
Email:
Affiliation:  Association Nationale de Prevention Medicale
Key inclusion & exclusion 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



Age minimum: 40 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Osteoarthritis
Intervention(s)
Dietary Supplement: ARTRONAT
Dietary Supplement: PLACEBO
Primary Outcome(s)
Reduction of gonalgia [Time Frame: T8 months]
Secondary Outcome(s)
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]
Secondary ID(s)
2011-A00319-32
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
RDVC Produit de Santé.
Association Nationale de Prévention Médicale.
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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