Study of Echinaforce Junior Tablets in Children With Acute Colds
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 3 x 1 tablet per day Echinaforce Junior tablets (low dose) |
|
| 5 x 1 tablet per day Echinaforce Junior tablets (high dose) |
Outcome Measures
Primary Outcome Measures
- tolerability assessment by physicians [4 months]
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"
Secondary Outcome Measures
- tolerability assessment by parents/child [4 months]
The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
- tolerability assessment by parents/child [10 days]
The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months
- Assessment of efficacy by parents/child [4 months]
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
- Assessment of Cold Symptoms during Acute Treatment [10 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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age between 4 and 12 years
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signed informed consent by parents and optionally be the child
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daily access to computer / internet
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competence of german language
Exclusion Criteria:
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13 years or older, younger than 4 years.
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presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
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participation in a clinical study in the past 30 days
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intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
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surgical intervention in the 3 months before inclusion or planned intervention during the observation period
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Known diabetes mellitus
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Known and treated allergic rhinitis, atopy or asthma
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cystic fibrosis, bronchopulmonic dysplasia, COPD
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immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or leukosis)
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metabolic or resorptive disorders
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liver or kidney diseases
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serious health problems
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predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia)
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known allergy to plants of the compositae family (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. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin | St. Gallen | Saint Gallen | Switzerland | 9000 |
Sponsors and Collaborators
- A. Vogel AG
Investigators
- Principal Investigator: Arnold Baechler, Dr. med., Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 920158