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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN07988058

Enrollment

308

Registered

2011-01-21

Start date

2010-05-28

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory infections (ARI) Respiratory Acute upper respiratory infections of multiple and unspecified sites

Interventions

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 be

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Efficacy to prevent ARI episodes 2. Security and adverse reactions 3. Medication compliance	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Chile

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026