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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-03-31

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.

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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PP1

Neurapas balance

Group Type EXPERIMENTAL

Neurapas balance

Intervention Type DRUG

6 tablets single dose

PP2

Pascoflair 425 mg

Group Type EXPERIMENTAL

Pascoflair 425 mg

Intervention Type DRUG

3 tablets , single dose

PL1

P-Tabletten weiß

Group Type PLACEBO_COMPARATOR

P-Tabletten weiß

Intervention Type DRUG

3 tablets, single dose

Interventions

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Neurapas balance

6 tablets single dose

Intervention Type DRUG

Pascoflair 425 mg

3 tablets , single dose

Intervention Type DRUG

P-Tabletten weiß

3 tablets, single dose

Intervention Type DRUG

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

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes