Echinacea Junior vs Vitamin C in Children 4-12 Years Old

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Respiratory Tract Infection Viral

Intervention / Treatment
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* Drug: Echinaforce


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 4-12 years written informed consent by parents and optionally by child daily Access to computer/email german language skills Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Echinaforce Junior Tablets<br>Hydroalcoholic extract of Echinacea purpurea herb and radix | Drug: Echinaforce<br> <br> * Other names: Echinacea purpurea;|
| Active Comparator: Vitamin C Tablets<br>synthetically produced ascorbic acid | Drug: Echinaforce<br> <br> * Other names: Echinacea purpurea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative number of cold days | total number of days with cold symptoms as per diary entries | 4 months prevention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | Occurrence of adverse events will be analysed by descriptive methods | 4 months prevention | 
| Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score) | 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 | 4 months prevention | 
| Incidence of respiratory tract infections (viral RTIs) | Occurrence of colds and flu episodes | 4 months prevention | 
| Acceptance in the view of the parents | Parents will judge the acceptance after 4 months (would you use the medicament again?) | 4 months prevention | 
| Occurrence of adverse drug reactions | Occurrence of adverse drug reactions will be analysed by descriptive methods | 4 months prevention | 
| Tolerability in view of the physician | physicians will judge tolerability as bad, moderate, good or very good | 4 months prevention | 
| Tolerability in view of the parents | parents will judge the tolerability after 2 and 4 months treatment as bad, moderate, good or very good | After 4 months prevention | 
| Efficacy in the view of the parents/children | Parents/children will give their subjective impression of efficacy by ratings bad, moderate, good or  very good. | 4 months prevention | 
| accompanying virus analytics | nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses | 4 months prevention | 
| effects on the endogenous defense | 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) | 4 months prevention | 
| Concomitant treatment and therapies | Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups | 4 months prevention |