The purpose of this study is to evaluate the efficacy and safety of two different drugs in the treatment of patients diagnosed with memory difficulties and a decline in cognitive function. This is a parallel distribution: a group of patients will be treated with a combination Panax Ginseng + Ginkgo Biloba + multivitamin + Polyminerals (EMS), and another group with Ginkgo Biloba (Tebonin ®).
STUDY DESIGN: * multicenter, phase III, double-blind, randomized entry of patients, prospective and comparative * The duration of the study: 60 days * 3 visits (days 1, 30 and 60) * Evaluate the effectiveness of the association * Evaluate the safety of the combination * Adverse events evaluation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
A tablet, 2 times daily (12/12 hours).
A tablet, 2 times daily (12/12 hours).
Cliníca Dr. Felício Savioli
Cotia, São Paulo, Brazil
Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin ®) for the symptomatic treatment of disorders of cognitive function.
To evaluate the efficacy of the association between Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin to treat patients with disorders of cognitive function compared to treatment with the drug Ginkgo Biloba (Tebonin ®) The assessment of effectiveness will be determined by statistical evaluation of the scores of responses related to quality of life questionnaires and psychometric tests (Mini-Mental Test and Test of Logical Memory WMS-R).
Time frame: 60 days
Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin ®) for the symptomatic treatment of disorders of cognitive function.
To evaluate the safety of the association between Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin to treat patients with disorders of cognitive function compared to treatment with the drug Ginkgo Biloba (Tebonin ®). The safety of the medication to be prescribed by the observation of adverse events and related to the study medication. Analysis of safety tests (biochemical profile, complete blood count, blood glucose, cholesterol and uric acid) requested at visit 1 and 2.
Time frame: 60 days
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