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Completed

NCT Number: NCT02971384

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

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dr. med. Mercedes Ogal

Brunnen, 6440, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Echinaforce

Drug

Other names: Echinacea purpurea

Primary outcomes

  1. cumulative number of cold days

    Time frame: 4 months prevention

    total number of days with cold symptoms as per diary entries

Secondary outcomes

  1. Occurrence of adverse events

    Time frame: 4 months prevention

    Occurrence of adverse events will be analysed by descriptive methods

  2. Analysis of duration and severity of respiratory episodes (single Symptoms and total symptom score)

    Time frame: 4 months prevention

    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

  3. Incidence of respiratory tract infections (viral RTIs)

    Time frame: 4 months prevention

    Occurrence of colds and flu episodes

  4. Acceptance in the view of the parents

    Time frame: 4 months prevention

    Parents will judge the acceptance after 4 months (would you use the medicament again?)

  5. Occurrence of adverse drug reactions

    Time frame: 4 months prevention

    Occurrence of adverse drug reactions will be analysed by descriptive methods

  6. Tolerability in view of the physician

    Time frame: 4 months prevention

    physicians will judge tolerability as "bad", "moderate", "good" or "very good"

  7. Tolerability in view of the parents

    Time frame: After 4 months prevention

    parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"

  8. Efficacy in the view of the parents/children

    Time frame: 4 months prevention

    Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".

  9. accompanying virus analytics

    Time frame: 4 months prevention

    nasal samples will be taken at occurrence of cold Symptoms and will be analysed for the presence of respiratory viruses

  10. effects on the endogenous defense

    Time frame: 4 months prevention

    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")

  11. Concomitant treatment and therapies

    Time frame: 4 months prevention

    Concomitant treatment and therapies will be coded using medical dictionary for Regulatory Agencies and will be analysed descriptively for the two treatment groups

Sponsors and collaborators

Lead sponsor

A. Vogel AG

Industry

Registry information

Official study 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)

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Nov 23, 2016
Registry last updated
May 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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