Controlled, Randomized, Double-blind, Multicentre Study on Efficacy and Safety of Echinaforce Junior Tablets in Comparison With Vitamin C for the Prevention of Viral Respiratory Tract Infections in Children (4-12 Years)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- A. Vogel AG
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- cumulative number of cold days
研究概览
简要总结
Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract infections.
详细描述
200 children aged 4-12 years are recruited by pediatricians and general practitioners and are allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C. Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment break and an intermediate study visit (V2). Thereafter children continue with preventive Treatment for another 2 months, followed by exclusion visit (V3).
Parents are required to contact a study coordinator at the occurrence of acute respiratory Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode parents will sample nasal secretion, which will be analysed for common respiratory agents.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4-12 years
- •written informed consent by parents and optionally by child
- •daily Access to computer/email
- •german language skills
排除标准
- •13 years or older, younger than 4 years
- •participation in a clinical study during past 30 days
- •intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin)
- •surgical intervention 3 months Prior to inclusion or planned intervention during the observation period
- •known Diabetes mellitus
- •known and treated atopy or Asthma
- •cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD)
- •diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis))
- •Metabolic or Resorption disorders
- •Liver or kidney diseases
- •Serious health Problems (e.g. neurological Problems)
- •known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product
研究组 & 干预措施
Echinaforce Junior Tablets
Hydroalcoholic extract of Echinacea purpurea herb and radix
干预措施: Echinaforce (Drug)
Vitamin C Tablets
synthetically produced ascorbic acid
干预措施: Echinaforce (Drug)
结局指标
主要结局
cumulative number of cold days
时间窗: 4 months prevention
total number of days with cold symptoms as per diary entries
次要结局
- Occurrence of adverse events(4 months prevention)
- Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)(4 months prevention)
- Incidence of respiratory tract infections (viral RTIs)(4 months prevention)
- Acceptance in the view of the parents(4 months prevention)
- Occurrence of adverse drug reactions(4 months prevention)
- Tolerability in view of the physician(4 months prevention)
- Tolerability in view of the parents(After 4 months prevention)
- Efficacy in the view of the parents/children(4 months prevention)
- accompanying virus analytics(4 months prevention)
- effects on the endogenous defense(4 months prevention)
- Concomitant treatment and therapies(4 months prevention)