ABSTRACT Pascoflair? 425 mg is a herbal drug based on Passiflora incarnata dry extract and is registered in different countries for the treatment of nervous restlessness and anxiety and also as an aid to sleep. The study was initiated for the quantitative assessment of the effect of this preparation on brain electric activity and cognition in human volunteers. Quantitative electroencephalographic current source density (CSD) from 16 healthy male and female human volunteers (average age 49 years) was used in a randomized, placebo-controlled crossover study. Data were taken 0.5, 1.5, 3 and 4 hours after administration of the preparations under the conditions of 6 minutes eyes open, 5 minutes d2 concentration test, mathematical calculation test and memory test respectively. During mental load, changes in spectral band power were used to analyse drug-induced effects. All variables were fed into a linear discriminant analysis (LDA) for comparison with other drug profiles. Spectral power in the delta and theta range was significantly attenuated at 3 and 4 hours after administration in comparison with the time-dependent increase normally observed due to circadian rhythm. Discriminant analysis revealed a difference to placebo for all recordings as early as 30 minutes after intake of 3 coated tablets of Pascoflair? 425 mg. Using LDA data location within the poly-dimensional space, verum was projected into the area of the effects of Gingko/Ginseng as reference drugs tested earlier under identical conditions. Psychometric performance was not disrupted. Pascoflair? 425 mg can be regarded as a well characterized plant-derived drug with anxiolytic and calming properties without negative sedative and cognition-attenuating side effects. Current results document the effecttiveness of the preparation as early as after 30 minutes. In addition, they indicate persistence of good mental performance for hours. Trial registration: the study has been registered at ClinicalTrials.gov under NCT01047605.
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