Condition category
Respiratory
Date applied
01/12/2010
Date assigned
21/01/2011
Last edited
21/01/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Sandro E Bustamante

ORCID ID

Contact details

Phytopharmacology Lab
Molecular And Clinical Pharmacology Programme
ICBM
Faculty of Medicine
University of Chile
Santiago
Stgo-07
Chile
sbustama@med.uchile.cl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Echinacea purpurea in the prevention of acute upper respiratory tract infections in children: a ramdomised, double-blind, placebo-controlled, multicentre trial

Acronym

EPIRA

Study hypothesis

Echinacea purpurea standardised extract prevents acute upper respiratory infections in children aged two to four years old.

Ethics approval

Scientific Ethics Committee, South Metropolitan Health Service approved on the 13th April 2010 (ref: Nº52/2010)

Study design

Multicentre double blind randomised placebo controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

1. Efficacy to prevent ARI episodes
2. Security and adverse reactions
3. Medication compliance

Secondary outcome measures

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.

Overall trial start date

28/05/2010

Overall trial end date

11/12/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

308

Participant 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

Recruitment start date

28/05/2010

Recruitment end date

11/12/2010

Locations

Countries of recruitment

Chile

Trial participating centre

Phytopharmacology Lab
Santiago
Stgo-07
Chile

Sponsor information

Organisation

Knop Laboratories (Chile)

Sponsor details

Av. Industrial 1198
Quilpué
6530382
Chile
mperez@knop.cl

Sponsor type

Industry

Website

Funders

Funder type

University/education

Funder name

University of Chile (Chile) - Molecular And Clinical Pharmacology Programme and Primary Care And Family Health Department

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Knop Laboratories (Chile)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes