Echinacea Junior vs Vitamin C in Children 4-12 Years Old

A. Vogel AG203 enrolled

Overview

Aim of this study is to investigate efficacy and safety of Echinaforce Junior Tablets (250mg) in comparison with Vitamin C tablets in the prevention of acute viral respiratory tract infections.

200 children aged 4-12 years are recruited by pediatricians and general practitioners and are allocated to preventive treatment with either Echinaforce Junior tablets or Vitamin C. Children take 3 x 1 tablet per day over a period of 2 months followed by 1 week treatment break and an intermediate study visit (V2). Thereafter children continue with preventive Treatment for another 2 months, followed by exclusion visit (V3). Parents are required to contact a study coordinator at the occurrence of acute respiratory Symptoms to initiate symptom recording via internet-based e-diary. On day 1 - 3 of episode parents will sample nasal secretion, which will be analysed for common respiratory agents.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

203

Conditions

Respiratory Tract Infection Viral

Interventions

EchinaforceDRUG

Eligibility

Sex: ALLMin age: 4 YearsMax age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 4-12 years * written informed consent by parents and optionally by child * daily Access to computer/email * german language skills Exclusion Criteria: * 13 years or older, younger than 4 years * participation in a clinical study during past 30 days * intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin) * surgical intervention 3 months Prior to inclusion or planned intervention during the observation period * known Diabetes mellitus * known and treated atopy or Asthma * cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD) * diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis)) * Metabolic or Resorption disorders * Liver or kidney diseases * Serious health Problems (e.g. neurological Problems) * known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product

Locations (1)

Dr. med. Mercedes Ogal

Brunnen, Switzerland