Healthy
Conditions
Keywords
qEEG, herbal medicine, cognitive function, Neurapas balance, Pascoflair, hypericum, passionflower, valerian, Healthy volunteers, Influence on quantitative electro-encephalogram (qEEG).
Brief summary
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.
Detailed description
Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.
Interventions
DRUGNeurapas balance
6 tablets single dose
DRUGPascoflair 425 mg
3 tablets , single dose
DRUGP-Tabletten weiß
3 tablets, single dose
Sponsors
Pascoe Pharmazeutische Praeparate GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female volunteers * 30 - 70 years (extremes included) * Medical history without any study relevant pathological findings * Written and signed informed consent
Exclusion criteria
* Clinically study relevant acute or chronic disorders, that can be detected by clinical investigation or medical history * Clinical, study-relevant pathological findings of clinical oar laboratory investigations * Clinically relevant pathological EEG findings (e.g. artefact-free parts in Screening-EEG \<30% in one recording * Clinically relevant allergies * positive alcohol testing on Screening, Day A, B, or C, or anamnestic * positive drug screening test on Screening, Day A, B, or C, or anamnestic * Intake of study relevant medication 14 days prior to active Day A, or during active study duration, based on the volunteer´s information * Regular intake of drug with primary central nervous effects (e.g. psychoactive drugs or central acting antihypertensive drugs) * Known hypersensitivity / allergy against herbal extracts (i.e. dry extracts of Passionflower herb, St. John´s Wort herb, Valerian root) or lactose or an other excipient of the investigational medication * Lapp-lactase deficiency (anamnestic) * Hypersensitivity of the skin (anamnestic) * BMI (Body-Mass-Index) \<18 or\>30 * Abuse of caffeine, teeine, or tobacco * Smoking in the investigational site on Day A, B, or C * Participation in an other clinical study within 60 days prior to Screening * Positive Pregnancy Test (on Screening, Day A, B, or C) or Lactation * Bad compliance * Revocation of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo) | 5 times within 4 h |
Secondary
| Measure | Time frame |
|---|---|
| Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3)) | 5 times wihtin 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6)) | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4) | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect | 5 times within 4 h |
| Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) | 5 times within 4 h |
Countries
Germany
Outcome results
None listed