Respiratory Tract Infection Viral
Conditions
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.
Interventions
DRUGEchinaforce
Sponsors
A. Vogel AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cumulative number of cold days | 4 months prevention | total number of days with cold symptoms as per diary entries |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| Occurrence of adverse events | 4 months prevention | Occurrence of adverse events will be analysed by descriptive methods |
| 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 |
| 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 |
Countries
Switzerland
Outcome results
None listed