Subjects who suffer from exam nerves
Conditions
Interventions
Trade Name: PASCOFLAIR®
Product Name: PASCOFLAIR®
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Passiflora incarnatadry extract preparation (5-7:1)
Other descriptive name: PASSIFLORA INCAR
Sponsors
PASCOE pharmazeutische Präparate GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy male and female subjects. Age between 18 and 40 years (both included). Anxiety questionnaire PAF (pre-selection of subjects) - values above T> 60 are regarded as conclusive. Inconclusive case history and diagnosis. Subject must be capable of giving informed consent. Acceptance of written consent to participate in the study after education in written and oral form (informed consent). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination. Clinically relevant pathological findings from clinical and laboratory findings. Presence of clinically relevant pathological EEG features or artifact-free portion of the screening EEG 32. Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day) or tobacco (more than 20 cigarettes per day). Smoking on day of A. Participation in another clinical trial within the last 60 days. Positive pregnancy test (day A). Lactation. Bad compliance. Cancellation of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Anxiolytic effects of PASCOFLAIR® shall be tested in subjects suffering from test anxiety after single intake by aid of a newly developed, validated method consisting of a combination of eye tracking (following glances) with neurocode tracking (quantitative EEG with a time resolution of 364 ms).;Secondary Objective: Primary outcome measures Comparison of verum and placebo efficacy is performed on electric power in 17 different brain regions within six frequency ranges defined as target parameters in the presence of different stress inducing cognitive tests or exciting video scenes (i.e. quiz , memory test, Stroop test). With respect to emotion parietal and temporal spectral beta power are evaluated, in the cognitive domain spectral frontal delta and theta power is taken as surrogate parameter during the different exposures. Secondary outcome measures Tolerability Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.;Primary end point(s): Primary outcome measures Comparison of verum and placebo efficacy is performed on electric power in 17 different brain regions within six frequency ranges defined as target parameters in the presence of different stress inducing cognitive tests or exciting video scenes (i.e. quiz , memory test, Stroop test). With respect to emotion parietal and temporal spectral beta power are evaluated, in the cognitive domain spectral frontal delta and theta power is taken as surrogate parameter during the different exposures. ;Timepoint(s) of evaluation of this end point: day A | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Tolerability Correlation between questionnaire items and spectral EEG power with regard to different frequency ranges.Please enter information in English and add any other language that is applicable;Timepoint(s) of evaluation of this end point: Final examination | — |
Countries
Germany
Contacts
Public ContactKlinische Forschung Dr. G. Weiß
PASCOE pharmazeutische Präparate GmbH
Outcome results
None listed