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

Upper Respiratory Tract Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01396889
• Other study ID #: Echinacea in URIs
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 20, 2011
• Start date: May 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2010
• Source: Hormozgan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 5 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Drug:
• Echinacea
0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
• Placebo
Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Hormozgan University of Medical Sciences (HUMS)	Bandar Abbas	Hormozgan

Sponsors (1)

Lead Sponsor	Collaborator
Hormozgan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of upper respiratory tract infection diagnosed by physician according to history and physical examination and laboratory tests if was necessary		6 months	No
Secondary	Drug side effects		6 months	Yes