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NCT01396889 Clinical Trial

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
Secondary ID
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

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
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