Clinical trial NCT02971384: Echinacea Junior vs Vitamin C in Children 4-12 Years Old
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Respiratory Tract Infection Viral
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2016-11-23
Enrollment: 203
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: cumulative number of cold days
timeFrame: 4 months prevention
Secondary outcomes:
measure: Occurrence of adverse events
timeFrame: 4 months prevention
measure: Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)
timeFrame: 4 months prevention
measure: Incidence of respiratory tract infections (viral RTIs)
timeFrame: 4 months prevention
measure: Acceptance in the view of the parents
timeFrame: 4 months prevention
measure: Occurrence of adverse drug reactions
timeFrame: 4 months prevention
measure: Tolerability in view of the physician
timeFrame: 4 months prevention
measure: Tolerability in view of the parents
timeFrame: After 4 months prevention
measure: Efficacy in the view of the parents/children
timeFrame: 4 months prevention
measure: accompanying virus analytics
timeFrame: 4 months prevention
measure: effects on the endogenous defense
timeFrame: 4 months prevention
measure: Concomitant treatment and therapies
timeFrame: 4 months prevention
Other outcomes:
Locations:
city: Brunnen
country: Switzerland
facility: Dr. med. Mercedes Ogal
Study officials:
affiliation: Arztpraxis für Kinder und Jugendliche
name: Mercedes Ogal, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.