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

This study has been completed.
Sponsor:
Information provided by:
Hormozgan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01396889
First received: July 18, 2011
Last updated: July 20, 2011
Last verified: May 2010
  Purpose

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 Intervention
Upper Respiratory Tract Infections
Drug: Echinacea
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hormozgan University of Medical Sciences:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Drug side effects [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: May 2010
Study Completion Date: July 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   1 Year to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396889

Locations
Iran, Islamic Republic of
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)
  More Information

No publications provided

Responsible Party: Roya Firoozi, Hormozgan University of Medical Sciences (HUMS)
ClinicalTrials.gov Identifier: NCT01396889     History of Changes
Other Study ID Numbers: Echinacea in URIs
Study First Received: July 18, 2011
Last Updated: July 20, 2011
Health Authority: Iran: Ministry of Health

Keywords provided by Hormozgan University of Medical Sciences:
Upper Respiratory Tract Infections
Echinacea
viral infections

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 16, 2014