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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
Change from baseline in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram (EEG) (post-shift)
Time frame: at day 77
Change in mental performance as measured by the completion of Cognitive Drug Research tasks (CDR tasks) combined with Electroencephalogram)
Time frame: up to day 77
Assessment of spontaneous Electroencephalogram (EEG) and event related potentials
Time frame: up to day 77
Assessment of Sleep-Electroencephalogram parameters
Time frame: Day -1, Day 1, Day 77
Evaluation of Quality of life scales
Time frame: up to day 77
Evaluation of Sleep by Visual Analogue Scale (VAS)
Time frame: up to day 77
Assessment of 24-hours holter Electrocardiogram (ECG)
Time frame: Day -1, Day1, Day 77
Assessment of urinary cortisol levels
Time frame: Day -1, Day1, Day 77
Number of patients with adverse events
Time frame: up to 3 months
Assessment of tolerability by investigator on a 4-point scale
Time frame: at day 77
Assessment of tolerability by subject on a 4-point scale
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Time frame: Day 41, Day 77