Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years

NCT01396889 — Not applicable, Completed, 100 participants, Hormozgan University of Medical Sciences

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Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital

Registry	NCT01396889
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	100 (Actual)
Sponsor	Hormozgan University of Medical Sciences (Other)
Conditions	Upper Respiratory Tract Infections
Interventions	Echinacea, Placebo (Drug)
Dates	start 2010-05-01, primary completion 2010-12-01, completion 2011-07-01, first posted 2011-07-19, last updated 2011-07-22
Locations	1 site in Iran

-Summary

Acute upper respiratory tract infections are the most commmon infections in children and are associated with complications such as acute otitis media, sinusitis and pneumonia. Echinacea is widely used for treatment of upper respiratoty tract infections. The aim of this study is to evaluate its efficacy as prophilaxis in children 1-5 years old.

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+Arms and interventions

Arm	Type	Interventions	Description
Echinacea	Experimental	Drug: Echinacea	0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months
Placebo	Placebo comparator	Drug: Placebo	Placebo

Echinacea (Drug), also known as American Cone Flower: 0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
Placebo (Drug): Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months

+Outcome measures

Primary outcomes

occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary [6 months]

Secondary outcomes

Drug side effects [6 months]

+Eligibility

Sex: All, ages: 1 Year to 5 Years, accepts healthy volunteers

Inclusion Criteria:

* Childrens 1-5 years old

Exclusion Criteria:

* Wheezing in previous 3 months requiring bronchodilatator
* History of hyperactive reactive airway
* using steroid or Echinacea
* chronic pulmonary of cardiac disease
* Acute respiratory disease within one week before study
* Allergic rhinitis
* Allergy to Echinacea
* avoiding to participate in the study

+Locations (1)

Facility	City	Country	Status
Hormozgan University of Medical Sciences (HUMS)	Bandar Abbas, Hormozgan	Iran

+Investigators

Roya Firoozi, Resident, Principal investigator, Hormozgan University of Medical Sciences (HUMS)

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