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

NCT ID: NCT01396889

Last Updated: 2011-07-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Upper Respiratory Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Echinacea

0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months

Group Type EXPERIMENTAL

Echinacea

Intervention Type DRUG

0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months

Interventions

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Echinacea

0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old

Intervention Type DRUG

Placebo

Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months

Intervention Type DRUG

Other Intervention Names

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American Cone Flower

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hormozgan University of Medical Sciences (HUMS)

Principal Investigators

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Roya Firoozi, Resident

Role: PRINCIPAL_INVESTIGATOR

Hormozgan University of Medical Sciences (HUMS)

Locations

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Hormozgan University of Medical Sciences (HUMS)

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

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Iran

Other Identifiers

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Echinacea in URIs

Identifier Type: -

Identifier Source: org_study_id

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