Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

Influenza Infection Clinical Trial

Official title:

Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01225770
• Other study ID #: CT2010001
• Status: Recruiting
• Phase: Phase 3
• First received: October 19, 2010
• Last updated: February 12, 2013
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: February 2013
• Source: University of Shizuoka
• Contact: Hiroshi Yamada, MD, PhD
• Phone: +81-54-264-5762
• Email: hyamada[@]u-shizuoka-ken.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

Experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. In this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.

Description:

Influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. It spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important.

Experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. In clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. Based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 640
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 15 Years to 20 Years

Eligibility

Inclusion Criteria:

• aged from 15 to 20 years

• obtained written informed consent from both the student and parent before participation

• possible to gargle during 90 days

• possible to fill in questionnaire

Exclusion Criteria:

• Possessing allergy to green tea

• Possessing history of influenza infection within 6 months before entering the study

• Possessing severe immune disease or whole body infection

• severe cardiac, respiratory, renal, or hepatic dysfunction

• diagnosed as inadequate to participate in the study by student doctor

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Influenza Infection
• Influenza, Human

Intervention

Dietary Supplement:
• green tea
Gargling three times daily for 90 days

Locations

Country	Name	City	State
Japan	University of Shizuoka	Shizuoka

Sponsors (1)

Lead Sponsor	Collaborator
University of Shizuoka

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence rates of influenza infection		Until 3 months gargling	No
Secondary	severity of influenza symptoms		until 3 months gargling	No
Secondary	influenza-free time during the study period		until 3 months gargling	No
Secondary	incidence of complications		until 3 months gargling	No
Secondary	incidence rates of upper respiratory tract infections		until 3 months gargling	No
Secondary	incidence of days of absence from school		until 3 months gargling	No
Secondary	occurrence of the adverse events		until 3 months gargling	Yes