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This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3 x 1 tablet per day | Echinaforce Junior tablets (low dose) | ||
| 5 x 1 tablet per day | Echinaforce Junior tablets (high dose) |
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| Measure | Description | Time Frame |
|---|---|---|
| tolerability assessment by physicians | Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as "very good", "good", "moderate" or "bad" | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| tolerability assessment by parents/child | The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months | 4 months |
| tolerability assessment by parents/child |
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Inclusion Criteria:
Exclusion Criteria:
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children aged 4 - 12 years recruited in pediatrics practice
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| Name | Affiliation | Role |
|---|---|---|
| Arnold Baechler, Dr. med. | Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin | Sankt Gallen | Canton of St. Gallen | 9000 | Switzerland |
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| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
| 10 days |
| Assessment of efficacy by parents/child | The acute efficacy of Echinaforce Junior is rated by the parents after every acute treatment period of 10 days as well as after the observation period of 4 months | 4 months |
| Assessment of Cold Symptoms during Acute Treatment | During acute colds parents complete a symptom diary and assess cold-related symptoms (runny and congested nose, sneezing, headache, joint pain, sore-throat, fever, cough, shivering, sleep quality, additional care) in the child | 10 days |