Safety and Efficacy of Long-term Treatment With Echinaforce® Over 4 Months
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 757
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse Drug Reactions
研究概览
简要总结
Extracts produced from Echinacea purpurea are traditionally used for the prevention and the acute treatment of influenzal infections like the common cold. The aim of this clinical study is to assess clinical safety and efficacy of a treatment with Echinacea in comparison to placebo. 750 healthy subjects with a history of equal or more than 2 cold episodes per year will be recruited during October and November 2009 and will be treated with either Echinacea or placebo over a period of 4 months.
Throughout the study period adverse events (AEs) and adverse drug reactions (AEs with at least a possible causal relation to the treatment) will be recorded.
Common cold related symptoms will be recorded in a daily diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •On average more than 2 cold episodes per year
- •Age above 18 years
- •Good physical condition
- •Signed informed consent
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)
研究组 & 干预措施
echinacea
干预措施: echinacea (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Occurrence of Adverse Drug Reactions
时间窗: 4 months
次要结局
- efficacy(4 months)