EUCTR2009-012297-12-GB进行中（未招募）不适用
Safety and Efficacy of long-term treatment with Echinaforce® over 4 months - Echinacea Safety Study
Bioforce AG0 个研究点目标入组 750 人开始时间: 2009年9月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 750
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
- •On average = 2 cold episodes per year
- •Age = 18 years
- •Good physical condition
- •Signed 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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Women without appropriate and effective contraception
- •Participation in a clinical trial 30 days prior to this trial
- •Pregnant or breast feeding women
- •Subjects with pre-existing cold symptoms for more than 24h at inclusion
- •Concurrent participation in another clinical trial
- •Intake of antimicrobial and/or antiviral medications at inclusion
- •Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 gr and / or 10 cigarettes per day)
- •Psychiatric disorders which may influence the results of the trial, epilepsy, suicide attempts
- •Planned surgical intervention during the trial.
- •Serious chronic diseases which influence the absorption, metabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukaemia, collagen disorders and multiple sclerosis
- •Known AIDS, HIV-infections and autoimmune diseases
- •Known diabetes mellitus (type 1)
- •Corticosteroid-treated asthma
- •Atopic and allergic subjects (under medicinal treatment)
- •Known allergy to plants of the composite family (Asteraceae)
研究者
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