Study of Echinaforce Junior Tablets in Children With Acute Colds

Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)

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.

Inclusion Criteria:

• 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 Criteria:

• 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