Echinacea Junior vs Vitamin C in Children 4-12 Years Old
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Echinaforce Junior Tablets Hydroalcoholic extract of Echinacea purpurea herb and radix |
Drug: Echinaforce
Other Names:
|
| Active Comparator: Vitamin C Tablets synthetically produced ascorbic acid |
Drug: Echinaforce
Other Names:
|
Outcome Measures
Primary Outcome Measures
- cumulative number of cold days [4 months prevention]
total number of days with cold symptoms as per diary entries
Secondary Outcome Measures
- 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
- 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"
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dr. med. Mercedes Ogal | Brunnen | Switzerland | 6440 |
Sponsors and Collaborators
- A. Vogel AG
Investigators
- Principal Investigator: Mercedes Ogal, Dr. med., Arztpraxis für Kinder und Jugendliche
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 5000120