Echinacea purpurea in the prevention of acute upper respiratory tract infections in children
| ISRCTN | ISRCTN07988058 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07988058 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Phytopharmacology Lab
Molecular And Clinical Pharmacology Programme
ICBM
Faculty of Medicine
University of Chile
Santiago
Stgo-07
Chile
| sbustama@med.uchile.cl |
Study information
| Study design | Multicentre double blind randomised placebo controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 28/05/2010 |
| Completion date | 11/12/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 4 Years |
| Sex | Both |
| Target number of participants | 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
Stgo-07
Chile
Sponsor information
Knop Laboratories (Chile)
Industry
Industry
Av. Industrial 1198
Quilpué
6530382
Chile
| mperez@knop.cl | |
"ROR" |
https://ror.org/043xarp69 |
Funders
Funder type
University/education
University of Chile (Chile) - Molecular And Clinical Pharmacology Programme and Primary Care And Family Health Department
No information available
Knop Laboratories (Chile)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
