EUCTR2014-003369-50-DE进行中（未招募）1 期
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.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •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, glucose-galactose 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.
- •Participation in another clinical trial within the last 60 days.
- •Positive pregnancy test (day A).
- •Bad compliance.
- •Cancellation of informed consent.
研究者
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