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The general aim of this study is to assess the effects of Pharmaton® Caplets on mental performance and physical fatigue in nurses and nursing auxiliaries working night shifts
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmaton® Caplets | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pharmaton® Caplets | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift) | at day 77 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram) | up to day 77 | |
| Assessment of spontaneous Electroencephalogram (EEG) and event related potentials | up to day 77 |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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|
| Assessment of Sleep-Electroencephalogram parameters | Day -1, Day 1, Day 77 |
| Evaluation of Quality of life scales | up to day 77 |
| Evaluation of Sleep by Visual Analogue Scale (VAS) | up to day 77 |
| Assessment of 24-hours holter Electrocardiogram (ECG) | Day -1, Day1, Day 77 |
| Assessment of urinary cortisol levels | Day -1, Day1, Day 77 |
| Number of patients with adverse events | up to 3 months |
| Assessment of tolerability by investigator on a 4-point scale | at day 77 |
| Assessment of tolerability by subject on a 4-point scale | Day 41, Day 77 |
| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |