Study of Echinaforce Junior Tablets in Children With Acute Colds

Respiratory Tract Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02198391
• Other study ID #: 920158
• Status: Completed
• Start date: October 15, 2014
• Est. completion date: August 7, 2015

Study information

• Verified date: May 2021
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 7, 2015
• Est. primary completion date: August 7, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Tract Diseases

Locations

Country	Name	City	State
Switzerland	Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin	St. Gallen	Saint Gallen

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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