Pharmacological Effects of Neurapas® Balance and Pascoflair® 425 mg on Brain Activity in Healthy Volunteers (NCAG 5209)

Pascoe Natural Healthcare

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: P-Tabletten weiß; Drug: Pascoflair 425 mg; Drug: Neurapas balance

Study type: Interventional

Funder types: Industry

Identifiers

NCT01047605

2009-015827-97 (EudraCT Number)

173 S 09 PSY

Details and patient eligibility

About

To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.

Full description

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

Enrollment: 16 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

PP1

Experimental group

Description:

Neurapas balance

Treatment:

Drug: Neurapas balance

PP2

Experimental group

Description:

Pascoflair 425 mg

Treatment:

Drug: Pascoflair 425 mg

PL1

Placebo Comparator group

Description:

P-Tabletten weiß

Treatment:

Drug: P-Tabletten weiß