Back to resultsImpact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
Primary Purpose
Upper Respiratory Tract Infections
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Echinacea
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infections focused on measuring Upper Respiratory Tract Infections, Echinacea, viral infections
Eligibility Criteria
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
Sites / Locations
- Hormozgan University of Medical Sciences (HUMS)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Echinacea
Placebo
Arm Description
0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months
Placebo
Outcomes
Primary Outcome Measures
occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary
Secondary Outcome Measures
Drug side effects
Full Information
NCT ID
NCT01396889
First Posted
July 18, 2011
Last Updated
July 20, 2011
Sponsor
Hormozgan University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01396889
Brief Title
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
Official Title
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hormozgan University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infections
Keywords
Upper Respiratory Tract Infections, Echinacea, viral infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Echinacea
Arm Type
Experimental
Arm Description
0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Echinacea
Other Intervention Name(s)
American Cone Flower
Intervention Description
0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months
Primary Outcome Measure Information:
Title
occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Drug side effects
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roya Firoozi, Resident
Organizational Affiliation
Hormozgan University of Medical Sciences (HUMS)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hormozgan University of Medical Sciences (HUMS)
City
Bandar Abbas
State/Province
Hormozgan
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
We'll reach out to this number within 24 hrs