Echinacea Junior vs Vitamin C in Children 4-12 Years Old
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|ClinicalTrials.gov Identifier: NCT02971384|
Recruitment Status : Completed
First Posted : November 23, 2016
Last Update Posted : May 4, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Tract Infection Viral||Drug: Echinaforce||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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)|
|Actual Study Start Date :||November 25, 2016|
|Actual Primary Completion Date :||August 3, 2017|
|Actual Study Completion Date :||July 3, 2018|
Experimental: Echinaforce Junior Tablets
Hydroalcoholic extract of Echinacea purpurea herb and radix
Other Name: Echinacea purpurea
Active Comparator: Vitamin C Tablets
synthetically produced ascorbic acid
Other Name: Echinacea purpurea
- cumulative number of cold days [ Time Frame: 4 months prevention ]total number of days with cold symptoms as per diary entries
- Occurrence of adverse events [ Time Frame: 4 months prevention ]Occurrence of adverse events will be analysed by descriptive methods
- 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
- Incidence of respiratory tract infections (viral RTIs) [ Time Frame: 4 months prevention ]Occurrence of colds and flu episodes
- 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?)
- Occurrence of adverse drug reactions [ Time Frame: 4 months prevention ]Occurrence of adverse drug reactions will be analysed by descriptive methods
- Tolerability in view of the physician [ Time Frame: 4 months prevention ]physicians will judge tolerability as "bad", "moderate", "good" or "very good"
- 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"
- 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".
- 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
- 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")
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971384
|Dr. med. Mercedes Ogal|
|Brunnen, Switzerland, 6440|
|Principal Investigator:||Mercedes Ogal, Dr. med.||Arztpraxis für Kinder und Jugendliche|