NCT01047605已完成1 期
Evaluation of the Pharmacological Effects of NEURAPAS® Balance and PASCOFLAIR® 425 mg by Quantitative Measurement of Brain Activity in 16 Healthy Volunteers. A Single-blinded, Randomised, Placebo-controlled, 3-armed Phase-I-study With Cross-over Design
Pascoe Pharmazeutische Praeparate GmbH1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2010年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)
研究概览
简要总结
To evaluate the pharmacological effects of two herbal medicinal products (Neurapas balance and Pascoflair 425 mg) in comparison to placebo on brain activity.
详细描述
Evaluation of the pharmacological effects of Neurapas® balance and Pascoflair® 425 mg by quantitative measurement of brain activity in 16 healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female volunteers
- •30 - 70 years (extremes included)
- •Medical history without any study relevant pathological findings
- •Written and signed informed consent
排除标准
- •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
研究组 & 干预措施
PP1
Experimental
Neurapas balance
干预措施: Neurapas balance (Drug)
PP2
Experimental
Pascoflair 425 mg
干预措施: Pascoflair 425 mg (Drug)
PL1
Placebo Comparator
P-Tabletten weiß
干预措施: P-Tabletten weiß (Drug)
结局指标
主要结局
Z1: qEEG (total): Median change of electrical activity (qEEG: of all electrode positions) compared to Baseline (PP1 vs PP2 vs Placebo)
时间窗: 5 times within 4 h
次要结局
- Comparison PP1 vs PP2 vs Placebo: Z2: qEEG (all frequencies, Clusters): Median change of electrical activity (qEEG: of selective brain-regional clusters of electrode positions) compared to Baseline(5 times within 4 h)
- Comparison PP1 vs PP2 vs Placebo: Z3:qEEG (d2, beta1 (Cluster F7/T3))(5 times wihtin 4 h)
- Comparison PP1 vs PP2 vs Placebo: Z4:qEEG (ME, theta (Cluster F7/T3/T6))(5 times within 4 h)
- Comparison PP1 vs PP2 vs Placebo: Z5:qEEG (KLT, theta (Cluster F7/T3) + alpha (Cluster T4/T6))(5 times within 4 h)
- Comparison PP1 vs PP2 vs Placebo: Z6: qEEG (Aa, all frequencies, Cluster C3/T3/P4)(5 times within 4 h)
- Comparison PP1 vs PP2 vs Placebo: Z7: Timely onset of effect and duration of effect(5 times within 4 h)
研究者
研究点 (1)
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