NCT02971384

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

Controlled, Randomized, Double-blind, Multicentre Study on Efficacy and Safety of Echinaforce Junior Tablets in Comparison With Vitamin C for the Prevention of Viral Respiratory Tract Infections in Children (4-12 Years)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: A. Vogel AG · Industry
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Respiratory Tract Infection Viral

Interventions

Type	Name	Description
DRUG	Echinaforce

Timeline

• Start date: 2016-11-25
• Primary completion: 2017-08-03
• Completion: 2018-07-03
• First posted: 2016-11-23
• Last updated: 2021-05-04

Locations

1 site across 1 country: Switzerland