EUCTR2014-004840-36-DE进行中（未招募）不适用
Proof of effectiveness of Calmvalera Hevert using qantitative measurement of electrical brain activity on 24 subjects during image and video-mediated cognitive and emotional stress.A double-blind, randomized, placebo-controlled, two-arm, Phase IV study in parallel design.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •Male and female subjects.
- •Age between 18 and 40 years (both included).
- •Test anxiety questionnaire PAF (preselection 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 24
- •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 to platinic (anamnestic)
- •Known intolerance / hypersensitivity (allergy) to plant derived extracts (Cimicifuga, Cocculos, Passiflora, Valeriana usw. ....) or any of the ingredients of the investigational product (anamnestic).
- •Presence of a rare, genetic disease such as fructose intolerance or lactose hypersensitivity (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
相似试验
招募中
4 期
Helicobacter pylori eradication therapy for high school students in Kyoto.Helicobacter pylori infectionJPRN-jRCTs051180235Takagi Tomohisa288,000
进行中（未招募）
不适用
EVALUATION OF EFFECT OF BLOWING IN A PIPE CONNECTED WITH BLOOD PRESSURE MEASURING MACHINE FOR REDUCING PROPOFOL PAICTRI/2016/12/007618Sanjay Gandhi Postgraduate Institute Of Medical Sciences Lucknow Uttar Pradesh India80
已完成
不适用
EVALUATION OF EFFECT OF BLOWING IN A PIPE CONNECTED WITH BLOOD PRESSURE MEASURING DEVICE FOR REDUCING LUMBAR PUNCTURE BACK PAICTRI/2014/09/005037Sanjay Gandhi Postgraduate Institute Of Medical Sciences90
已完成
不适用
To determine the safety and effectiveness of Hair Fall Control Oil Shots in hair fall reduction in Healthy Adult Human Subjects with Hair FallCTRI/2022/04/041710Brillare Science Private Limited16
已完成
不适用
To check the Safety and Effectiveness of Hair Fall Control Shampoo in Healthy Adult Human Subjects with Hair Fall ComplaintsCTRI/2022/08/044868Vasu Healthcare Private Limited Vasu Research Centre32