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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echinaforce Junior Tablets | Experimental | Hydroalcoholic extract of Echinacea purpurea herb and radix |
|
| Vitamin C Tablets | Active Comparator | synthetically produced ascorbic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Echinaforce | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| cumulative number of cold days | total number of days with cold symptoms as per diary entries | 4 months prevention |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mercedes Ogal, Dr. med. | Arztpraxis für Kinder und Jugendliche | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. med. Mercedes Ogal | Brunnen | 6440 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33832544 | Derived | Ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic usage in children through respiratory tract infection prevention: a randomized, blinded, controlled clinical trial. Eur J Med Res. 2021 Apr 8;26(1):33. doi: 10.1186/s40001-021-00499-6. |
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| ID | Term |
|---|---|
| C583535 | Echinaforce |
| C000718679 | Echinacea extract |
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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 |