Status:
COMPLETED
Study of Echinaforce Junior Tablets in Children With Acute Colds
Lead Sponsor:
A. Vogel AG
Conditions:
Respiratory Tract Diseases
Eligibility:
All Genders
4-12 years
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.
Eligibility Criteria
Inclusion
- age between 4 and 12 years
- signed informed consent by parents and optionally be the child
- daily access to computer / internet
- competence of german language
Exclusion
- 13 years or older, younger than 4 years.
- presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
- participation in a clinical study in the past 30 days
- intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
- surgical intervention in the 3 months before inclusion or planned intervention during the observation period
- Known diabetes mellitus
- Known and treated allergic rhinitis, atopy or asthma
- cystic fibrosis, bronchopulmonic dysplasia, COPD
- immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or leukosis)
- metabolic or resorptive disorders
- liver or kidney diseases
- serious health problems
- predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia)
- known allergy to plants of the compositae family (camomile or dandelion) or any of the substances of the investigational product
Key Trial Info
Start Date :
October 15 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 7 2015
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT02198391
Start Date
October 15 2014
End Date
August 7 2015
Last Update
May 4 2021
Active Locations (1)
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1
Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin
Sankt Gallen, Canton of St. Gallen, Switzerland, 9000