Echinacea Junior vs Vitamin C in Children 4-12 Years Old
- Conditions
- Respiratory Tract Infection Viral
- Interventions
- Drug: Echinaforce
- Registration Number
- NCT02971384
- Lead Sponsor
- A. Vogel AG
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 203
- 4-12 years
- written informed consent by parents and optionally by child
- daily Access to computer/email
- german language skills
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin C Tablets Echinaforce synthetically produced ascorbic acid Echinaforce Junior Tablets Echinaforce Hydroalcoholic extract of Echinacea purpurea herb and radix
- Primary Outcome Measures
Name Time Method cumulative number of cold days 4 months prevention total number of days with cold symptoms as per diary entries
- Secondary Outcome Measures
Name Time Method Acceptance in the view of the parents 4 months prevention Parents will judge the acceptance after 4 months (would you use the medicament again?)
Occurrence of adverse drug reactions 4 months prevention Occurrence of adverse drug reactions will be analysed by descriptive methods
Tolerability in view of the physician 4 months prevention physicians will judge tolerability as "bad", "moderate", "good" or "very good"
Tolerability in view of the parents After 4 months prevention parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
Occurrence of adverse events 4 months prevention Occurrence of adverse events will be analysed by descriptive methods
Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score) 4 months prevention Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups
Incidence of respiratory tract infections (viral RTIs) 4 months prevention Occurrence of colds and flu episodes
Efficacy in the view of the parents/children 4 months prevention Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
accompanying virus analytics 4 months prevention nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses
effects on the endogenous defense 4 months prevention Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")
Concomitant treatment and therapies 4 months prevention Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups
Trial Locations
- Locations (1)
Dr. med. Mercedes Ogal
🇨🇭Brunnen, Switzerland