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

A. Vogel AG

Status and phase

Completed

Phase 3

Conditions

Respiratory Tract Infection Viral

Treatments

Drug: Echinaforce

Study type

Interventional

Funder types

Industry

Identifiers

NCT02971384

5000120

Details and patient eligibility

About

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.

Full description

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.

Enrollment

203 patients

Sex

All

Ages

4 to 12 years old

Volunteers

Accepts Healthy Volunteers

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