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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01396889
Recruitment Status : Completed
First Posted : July 19, 2011
Last Update Posted : July 22, 2011
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 18, 2011
First Posted Date  ICMJE July 19, 2011
Last Update Posted Date July 22, 2011
Study Start Date  ICMJE May 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2011)
Drug side effects [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years
Official Title  ICMJE Impact of Echinacea as Prophilaxis for Upper Respiratory Tract Infections in Children 1-5 Years in Bandarabbas Children' Hospital
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Upper Respiratory Tract Infections
Intervention  ICMJE
  • Drug: Echinacea
    0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
    Other Name: American Cone Flower
  • Drug: Placebo
    Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months
Study Arms  ICMJE
  • Experimental: Echinacea
    0.5ml daily for children 1-2 years old and 2ml daily for children2-5 years old for 3 months
    Intervention: Drug: Echinacea
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2011)
100
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2011
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01396889
Other Study ID Numbers  ICMJE Echinacea in URIs
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Roya Firoozi, Hormozgan University of Medical Sciences (HUMS)
Study Sponsor  ICMJE Hormozgan University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Roya Firoozi, Resident Hormozgan University of Medical Sciences (HUMS)
PRS Account Hormozgan University of Medical Sciences
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP