Echinacea purpurea in the prevention of acute upper respiratory tract infections in children

ISRCTN	ISRCTN07988058
DOI	https://doi.org/10.1186/ISRCTN07988058
Protocol serial number	N/A
Sponsor	Knop Laboratories (Chile)
Funders	University of Chile (Chile) - Molecular And Clinical Pharmacology Programme and Primary Care And Family Health Department, Knop Laboratories (Chile)

Submission date: 01/12/2010
Registration date: 21/01/2011
Last edited: 21/01/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Sandro E Bustamante
Scientific

Phytopharmacology Lab
Molecular And Clinical Pharmacology Programme
ICBM
Faculty of Medicine
University of Chile
Santiago
Stgo-07
Chile

Email	sbustama@med.uchile.cl

Study information

Primary study design	Interventional
Study design	Multicentre double blind randomised placebo controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Echinacea purpurea in the prevention of acute upper respiratory tract infections in children: a ramdomised, double-blind, placebo-controlled, multicentre trial
Study acronym	EPIRA
Study objectives	Echinacea purpurea standardised extract prevents acute upper respiratory infections in children aged two to four years old.
Ethics approval(s)	Scientific Ethics Committee, South Metropolitan Health Service approved on the 13th April 2010 (ref: Nº52/2010)
Health condition(s) or problem(s) studied	Acute respiratory infections (ARI)
Intervention	Patients will be randomised to receive Echinacea purpurea standardised extract or placebo for 6 weeks. The total duration of follow up will be 24 weeks. Patients and carers will follow the schedule below. Visit 1a: Inclusion/exclusion criteria flow chart, informed consent. Visit 1b (Baseline): medical hystory, current medical status, physical examination. Start first set of blind medication (5 ml/12 h, po). Visit 2 (week 3): current medical status, physical examination. Start second set of blind medication (5 ml/12 h, po). Visit 3 (week 6): current medical status, physical examination. End blind medication. Visit 4 (week 10): current medical status, physical examination. Visit 5 (week 14): current medical status, physical examination. Visit 6 (week 19): current medical status, physical examination. Visit 7 (week 24): current medical status, physical examination.
Intervention type	Other
Primary outcome measure(s)	1. Efficacy to prevent ARI episodes 2. Security and adverse reactions 3. Medication compliance
Key secondary outcome measure(s)	1. Eficacy: 1.1. Number of ARI episodes 1.2. Duration of ARI episodes (days) 1.3. Severity of ARI episodes (fever, cough, nasal secretions, difficult to breath)* 2. Security and adverse reaction: 2.1. Qualitative description 2.2. Quantitative description 3. Medication compliance: It is considered compliant if he or she took at least 80% of the indicated dose by comparing the weight of bottles of study medication for patients prior to and after their intervention periods to determine the volume used. *Criteria and scores available on request.
Completion date	11/12/2010

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	2 Years
Upper age limit	4 Years
Sex	All
Target sample size at registration	308
Key inclusion criteria	1. Male/female healthy children aged 2 years to 4 years 11 months 2. Participants must be registered in just one of the seven centres of the study 3. A responsible adult must care him/her 24 hours/7 days of the child 4. Only one child per family may be enrolled 5. Parents must sign Informed Conset
Key exclusion criteria	1. Children with any cronic pathology or immune system disease 2. Allergy to Asteraceae family (coneflowers, sunflowers) 3. Viral or bacterial disease, related or not to ARI, diarrhoea, vomiting or digestive symptoms at start date 4. Hepatic or renal insuficiency 5. Surgery or treatment with drugs that modify immunological system until 60 days previous to start date
Date of first enrolment	28/05/2010
Date of final enrolment	11/12/2010

Locations

Countries of recruitment

Chile

Study participating centre

Phytopharmacology Lab

Santiago
Stgo-07
Chile

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes