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)

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infection Viral
• Intervention / Treatment: Drug: Echinaforce

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.

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Phase 3

Contacts and Locations

Study Locations

• Switzerland
  • Brunnen, Switzerland, 6440
    • Dr. med. Mercedes Ogal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Echinaforce Junior Tablets; Hydroalcoholic extract of Echinacea purpurea herb and radix	Drug: Echinaforce; Other Names: Echinacea purpurea
Active Comparator: Vitamin C Tablets; synthetically produced ascorbic acid	Drug: Echinaforce; Other Names: Echinacea purpurea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulative number of cold days	total number of days with cold symptoms as per diary entries	4 months prevention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of adverse events	Occurrence of adverse events will be analysed by descriptive methods	4 months prevention
Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)	Patients will rate respiratory symptoms in a diary at occurrence of acute respiratory tract infections and the entries will be analysed descriptively for the two treatment groups	4 months prevention
Incidence of respiratory tract infections (viral RTIs)	Occurrence of colds and flu episodes	4 months prevention
Acceptance in the view of the parents	Parents will judge the acceptance after 4 months (would you use the medicament again?)	4 months prevention
Occurrence of adverse drug reactions	Occurrence of adverse drug reactions will be analysed by descriptive methods	4 months prevention
Tolerability in view of the physician	physicians will judge tolerability as "bad", "moderate", "good" or "very good"	4 months prevention
Tolerability in view of the parents	parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"	After 4 months prevention
Efficacy in the view of the parents/children	Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".	4 months prevention
accompanying virus analytics	nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses	4 months prevention
effects on the endogenous defense	Question will be asked " do you think that the prevention had the follwing effects on the endogenous defense in your child?" (unchanged; improved; significantly improved")	4 months prevention
Concomitant treatment and therapies	Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups	4 months prevention

Collaborators and Investigators

• Sponsor: A. Vogel AG
• Investigators: Principal Investigator: Mercedes Ogal, Dr. med., Arztpraxis für Kinder und Jugendliche

Publications and helpful links

General Publications

• Ogal M, Johnston SL, Klein P, Schoop R. Echinacea reduces antibiotic usage in children through respiratory tract infection prevention: a randomized, blinded, controlled clinical trial. Eur J Med Res. 2021 Apr 8;26(1):33. doi: 10.1186/s40001-021-00499-6.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2016
• Primary Completion (Actual): August 3, 2017
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: November 16, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 23, 2016

Study Record Updates

• Last Update Posted (Actual): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Virus Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 5000120

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No