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Canceled [By sponsor decision)](streamdown:incomplete-link)
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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 Ā®).
STUDY DESIGN:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Group | Experimental | Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin - 1 tablet, 2 times a day (12/12 hours). |
|
| Comparator Group | Active Comparator | Ginkgo Biloba (Tebonin Ā®) - 1 tablet, 2 times a day (12/12 hours). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin | Drug | A tablet, 2 times daily (12/12 hours). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin Ā®) 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 Ā®) 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). | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| Study to evaluate the efficacy and safety of the association Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamins compared to Ginkgo Biloba (Tebonin Ā®) 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 Ā®). 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| FelĆcio MD Savioli Neto | ClĆnica Dr. FelĆcio Savioli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClinĆca Dr. FelĆcio Savioli | Cotia | SĆ£o Paulo | 06710-670 | Brazil |
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| ID | Term |
|---|---|
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
| D000096983 | Ginkgo Extract |
| C067316 | Geritol |
| C063170 | Ginkgo biloba extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Ginkgo Biloba (TeboninĀ®) | Drug | A tablet, 2 times daily (12/12 hours). |
|
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| 60 days |
| D013568 | Pathological Conditions, Signs and Symptoms |