Pharmacological Effects of Pascoflair® on Brain Activity in Patients Suffering From Test Anxiety

Pascoe Natural Healthcare

Status and phase

Completed

Phase 4

Conditions

Test Anxiety

Brain Activity

Passiflora Incarnata

Stress

Treatments

Other: Placebo

Drug: Pascoflair

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT05049447

200S14PF

Details and patient eligibility

About

Proof of effectiveness of Pascoflair using qantitative measurement of electric brain activity during examination stress in 40 subjects suffering from test anxiety. A double-blind, randomized, placebo-controlled, 2-armed, Phase IV study in parallel design.

Full description

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).

Enrollment

40 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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).

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 <30%.
Clinically relevant allergic symptoms.
Detection of alcohol at the time of initial examination (day SC) or on study day A (positive alcohol test) or by case history.
Detection of drugs (positive drug test) at the time of initial examination (day SC).
Consumption of clinically relevant medication during last fourteen days before and during the active study period based on the notification of the subject or his case history.
Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensives).
Known intolerance / hypersensitivity (allergy) to plant derived extracts (Passion flower dry extract) or any of the ingredients of the investigational product (anamnestic).
Presence of a rare, genetic disease such as fructose intolerance, glucosegalactose malabsorption or sucrase-isomaltase deficiency (anamnestic).
BMI (Body Mass Index) <18 or> 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.