Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers

Study Overview
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Brief Summary
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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
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Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.

Official Title
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Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design

Conditions
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Healthy

Intervention / Treatment
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* Drug: Neurapas balance
* Drug: Pascoflair 425 mg
* Drug: P-Tabletten weiß


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PP1<br>Neurapas balance | Drug: Neurapas balance<br>* 6 tablets single dose<br>|
| Experimental: PP2<br>Pascoflair 425 mg | Drug: Pascoflair 425 mg<br>* 3 tablets , single dose<br>|
| Placebo Comparator: PL1<br>P-Tabletten weiß | Drug: P-Tabletten weiß<br>* 3 tablets, single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6)) |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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qEEG, herbal medicine, cognitive function, Neurapas balance, Pascoflair, hypericum, passionflower, valerian, Healthy volunteers, Influence on quantitative electro-encephalogram (qEEG).