Study of Echinaforce Junior Tablets in Children With Acute Colds

NCT02198391 | Completed

• 1 other identifier: 920158
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Diseases

Outcome Measures

Primary Outcomes (1)

• tolerability assessment by physicians

  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"

  4 months

Secondary Outcomes (4)

• tolerability assessment by parents/child

  4 months

• tolerability assessment by parents/child

  10 days

• Assessment of efficacy by parents/child

  4 months

• Assessment of Cold Symptoms during Acute Treatment

  10 days

Study Arms (2)

3 x 1 tablet per day

Echinaforce Junior tablets (low dose)

5 x 1 tablet per day

Echinaforce Junior tablets (high dose)

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

children aged 4 - 12 years recruited in pediatrics practice

You may qualify if:

• 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

You may not qualify if:

• years or older, younger than 4 years.
• 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
• 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

Sponsors & Collaborators

• A. Vogel AG: lead

Study Sites (1)

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

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

Location

MeSH Terms

Conditions

Respiratory Tract Diseases

Study Officials

• Arnold Baechler, Dr. med.

  Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2014
• First Posted: July 23, 2014
• Study Start: October 15, 2014
• Primary Completion: August 7, 2015
• Study Completion: August 7, 2015
• Last Updated: May 4, 2021

Record last verified: 2021-05

Locations

CH (1)