Study of Echinaforce Junior Tablets in Children With Acute Colds

Study Overview
=================
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.

Official Title
-----------------
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)

Conditions
-----------------
Respiratory Tract Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 3 x 1 tablet per day<br>Echinaforce Junior tablets (low dose) | |
| 5 x 1 tablet per day<br>Echinaforce Junior tablets (high dose) | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |