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

Respiratory Tract Infection Viral Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02971384
• Other study ID #: 5000120
• Status: Completed
• Phase: Phase 3
• Start date: November 25, 2016
• Est. completion date: July 3, 2018

Study information

• Verified date: December 2017
• Source: Bioforce AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 3, 2018
• Est. primary completion date: August 3, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infection Viral
• Respiratory Tract Infections
• Virus Diseases

Intervention

Drug:
• Echinaforce

Locations

Country	Name	City	State
Switzerland	Dr. med. Mercedes Ogal	Brunnen

Sponsors (1)

Lead Sponsor	Collaborator
Bioforce AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cumulative number of cold days	total number of days with cold symptoms as per diary entries	4 months prevention
Secondary	Occurrence of adverse events	Occurrence of adverse events will be analysed by descriptive methods	4 months prevention
Secondary	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
Secondary	Incidence of respiratory tract infections (viral RTIs)	Occurrence of colds and flu episodes	4 months prevention
Secondary	Acceptance in the view of the parents	Parents will judge the acceptance after 4 months (would you use the medicament again?)	4 months prevention
Secondary	Occurrence of adverse drug reactions	Occurrence of adverse drug reactions will be analysed by descriptive methods	4 months prevention
Secondary	Tolerability in view of the physician	physicians will judge tolerability as "bad", "moderate", "good" or "very good"	4 months prevention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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