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

Sponsor
Hormozgan University of Medical Sciences (Other)
Overall Status
Completed
CT.gov ID
NCT01396889
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
14
Duration (Months)
7.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Echinacea

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

Drug: Echinacea
0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
Other Names:
  • American Cone Flower

    		•
    Placebo Comparator: Placebo

    Placebo

    Drug: Placebo
    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 Outcome Measures

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

    Secondary Outcome Measures

    1. Drug side effects [6 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hormozgan University of Medical Sciences (HUMS) Bandar Abbas Hormozgan Iran, Islamic Republic of

    Sponsors and Collaborators

    • Hormozgan University of Medical Sciences

    Investigators

    • Principal Investigator: Roya Firoozi, Resident, Hormozgan University of Medical Sciences (HUMS)

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01396889
    Other Study ID Numbers:
    • Echinacea in URIs
    First Posted:
    Jul 19, 2011
    Last Update Posted:
    Jul 22, 2011
    Last Verified:
    May 1, 2010
    Keywords provided by , ,
    Upper Respiratory Tract Infections
    Echinacea
    viral infections
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections

    Study Results

    No Results Posted as of Jul 22, 2011