Elderly, Osteoarthritis, Treatment
Conditions
Keywords
chondroitin, glucosamine, osteoarthritis
Brief summary
Primary Objective: To compare, after 12 weeks of double-blind treatment, the evolution of the improvement of pain (at rest and during / after exercise) in the questionnaire WOMAC (Western Ontario and McMaster Universities Arthritis Index), achieved with Condroflex ® oral administration(sulfate glucosamine + chondroitin sulfate sodium) in association with therapeutic exercises, compared to placebo in association with therapeutic exercises in individuals with knee OA and not exposed to prior treatment with the products under investigation.
Detailed description
To have osteoarthritis degree 2 or 3 / To be capable to consent
Interventions
OTHERcondroflex and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
OTHERsugar pill and exercise
1 sachet oral once a day by 12 Weeks / therapeutic exercise 3 times a week
Sponsors
Zodiac Produtos Farmaceuticos S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* to have knee osteoarthritis degree 2 or 3 * to be capable to consent
Exclusion criteria
* previous drug treatment * concomitant diseases * concomitant drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| improvement of pain | 12 week |
Secondary
| Measure | Time frame |
|---|---|
| rigidity restriction | 12 week |
Countries
Brazil
Contacts
Primary ContactSuely Roizenblatt
Backup ContactMagda Bignotto
Outcome results
None listed