Study of Echinaforce Junior Tablets in Children With Acute Colds

Overview

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.

Full Title of Study: “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)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 7, 2015

Arms, Groups and Cohorts

  • 3 x 1 tablet per day
    • Echinaforce Junior tablets (low dose)
  • 5 x 1 tablet per day
    • Echinaforce Junior tablets (high dose)

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Years

Maximum Age: 12 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • A. Vogel AG
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Arnold Baechler, Dr. med., Principal Investigator, Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.