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Completed

NCT Number: NCT02198391

Study of Echinaforce Junior Tablets in Children With Acute Colds

This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.

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Key information

Conditions

Respiratory Tract Diseases

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age between 4 and 12 years
  • signed informed consent by parents and optionally be the child
  • daily access to computer / internet
  • competence of german language

Exclusion criteria

  • 13 years or older, younger than 4 years.
  • presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
  • participation in a clinical study in the past 30 days
  • intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
  • surgical intervention in the 3 months before inclusion or planned intervention during the observation period
  • Known diabetes mellitus
  • Known and treated allergic rhinitis, atopy or asthma
  • cystic fibrosis, bronchopulmonic dysplasia, COPD
  • immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or leukosis)
  • metabolic or resorptive disorders
  • liver or kidney diseases
  • serious health problems
  • predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia)
  • known allergy to plants of the compositae family (camomile or dandelion) or any of the substances of the investigational product

Treatment and study plan

Primary outcomes

  1. tolerability assessment by physicians

    Time frame: 4 months

    Within the observation period of 4 months a maximum of 3 colds can be treated with Echinaforce Junior tablets at the indicated dosage. At the exclusion visit the physicians rate the tolerability of Echinaforce Junior tablets as "very good", "good", "moderate" or "bad"

Secondary outcomes

  1. tolerability assessment by parents/child

    Time frame: 4 months

    The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months

  2. tolerability assessment by parents/child

    Time frame: 10 days

    The tolerability of Echinaforce Junior is assessed after every acute treatment period of 10 days and after the observation period of 4 months

  3. Assessment of efficacy by parents/child

    Time frame: 4 months

    The acute efficacy of Echinaforce Junior is rated by the parents after every acute treatment period of 10 days as well as after the observation period of 4 months

  4. Assessment of Cold Symptoms during Acute Treatment

    Time frame: 10 days

    During acute colds parents complete a symptom diary and assess cold-related symptoms (runny and congested nose, sneezing, headache, joint pain, sore-throat, fever, cough, shivering, sleep quality, additional care) in the child

Sponsors and collaborators

Lead sponsor

A. Vogel AG

Industry

Registry information

Official study title

Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 23, 2014
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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