Dr. med. Mercedes Ogal
Brunnen, 6440, Switzerland
NCT Number: NCT02971384
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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Notify Me4 year–12 year
All sexes
Interventional
Phase 3
Brunnen, 6440, Switzerland
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Echinacea purpurea
Time frame: 4 months prevention
total number of days with cold symptoms as per diary entries
Time frame: 4 months prevention
Occurrence of adverse events will be analysed by descriptive methods
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
Time frame: 4 months prevention
Occurrence of colds and flu episodes
Time frame: 4 months prevention
Parents will judge the acceptance after 4 months (would you use the medicament again?)
Time frame: 4 months prevention
Occurrence of adverse drug reactions will be analysed by descriptive methods
Time frame: 4 months prevention
physicians will judge tolerability as "bad", "moderate", "good" or "very good"
Time frame: After 4 months prevention
parents will judge the tolerability after 2 and 4 months treatment as "bad", "moderate", "good" or "very good"
Time frame: 4 months prevention
Parents/children will give their subjective impression of efficacy by ratings "bad", "moderate", "good" or " very good".
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
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")
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
A. Vogel AG
Industry
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)
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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