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

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

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.

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections
• Intervention / Treatment: Drug: Echinacea; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar Abbas, Hormozgan, Iran, Islamic Republic of
      • Hormozgan University of Medical Sciences (HUMS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 5 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Drug side effects	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Echinacea; Upper Respiratory Tract Infections; viral infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: Echinacea in URIs