We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01396889
First Posted: July 19, 2011
Last Update Posted: July 22, 2011
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.
Information provided by:
Hormozgan University of Medical Sciences
  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
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

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 ]

Secondary Outcome Measures:
  • Drug side effects [ Time Frame: 6 months ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 5 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Roya Firoozi, Hormozgan University of Medical Sciences (HUMS)
ClinicalTrials.gov Identifier: NCT01396889     History of Changes
Other Study ID Numbers: Echinacea in URIs
First Submitted: July 18, 2011
First Posted: July 19, 2011
Last Update Posted: July 22, 2011
Last Verified: May 2010

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