Study of Echinaforce Junior Tablets in Children With Acute Colds

A. Vogel AG

Status: Completed

Conditions: Respiratory Tract Diseases

Study type: Observational

Funder types: Industry

Identifiers

NCT02198391

920158

Details and patient eligibility

About

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.

Enrollment: 79 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

79 participants in 2 patient groups

3 x 1 tablet per day

Description:

Echinaforce Junior tablets (low dose)

5 x 1 tablet per day

Description:

Echinaforce Junior tablets (high dose)