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The primary objective of this study was to assess the efficacy and safety of Gingko biloba film-coated tablets in improving cognitive function and neuropsychological functioning of middle-aged cognitively intact adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gingko biloba | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gingko biloba | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline of the cognitive test/CDR (Cognitive Drug Research) factor "Power of Attention) | pre-dose and 2, 4, 6 hours post-dosing at baseline and day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in CDR factors | pre-dose and 2, 4, 6 hours post-dosing at baseline, days 28 and 56 | |
| Changes from baseline in Stroop Colour and Word Test | Baseline and day 56 | |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000096983 | Ginkgo Extract |
| ID | Term |
|---|---|
| D010936 | Plant Extracts |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Changes from baseline in the Selective Reminding Test |
| Baseline and day 56 |
| Changes from baseline in the Trail Making Test (Part A and B) | Baseline and day 56 |
| Number of patients with adverse events | up to 56 days |
| Number of patients with clinically significant changes in vital signs | Baseline, days 28 and 56 |
| Number of patients with abnormal changes in laboratory parameters | Baseline and day 56 |
| Assessment of tolerability by subject on a 4-point scale | Days 28 and 58 |
| Assessment of tolerability by investigator on a 4-point scale | Days 28 and 58 |