Echinacea Junior vs Vitamin C in Children 4-12 Years Old

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-25

Study Completion Date

2018-07-03

Brief Summary

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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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Detailed Description

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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.

Conditions

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Respiratory Tract Infection Viral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Echinaforce Junior Tablets

Hydroalcoholic extract of Echinacea purpurea herb and radix

Group Type EXPERIMENTAL

Echinaforce

Intervention Type DRUG

Vitamin C Tablets

synthetically produced ascorbic acid

Group Type ACTIVE_COMPARATOR

Echinaforce

Intervention Type DRUG

Interventions

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Echinaforce

Intervention Type DRUG

Other Intervention Names

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Echinacea purpurea

Eligibility Criteria

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Inclusion Criteria

* 4-12 years
* written informed consent by parents and optionally by child
* daily Access to computer/email
* german language skills

Exclusion Criteria

* 13 years or older, younger than 4 years
* participation in a clinical study during past 30 days
* intake of antimicrobial, antiviral, immunosuppressive substances, salicylic medicaments (like Aspirin)
* surgical intervention 3 months Prior to inclusion or planned intervention during the observation period
* known Diabetes mellitus
* known and treated atopy or Asthma
* cystic fibrosis, bronchopulmonary dysplasia, chronic obstructive pulmonary disease (COPD)
* diseases of the immunosystem (like autoimmune disorders, degenerative illnesses (like AIDS or leucosis))
* Metabolic or Resorption disorders
* Liver or kidney diseases
* Serious health Problems (e.g. neurological Problems)
* known allergies against compositae (e.g. camomile or dandelion) or any of the substances of the investigational product

Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes