Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

February 12, 2013 updated by: University of Shizuoka

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 16 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Green tea
Gargling with green tea
Dietary supplement: green tea
Gargling three times daily for 90 days
Active Comparator: water
Gargling with water
Dietary supplement: green tea
Gargling three times daily for 90 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the incidence rates of influenza infection
Time Frame: Until 3 months gargling
Until 3 months gargling

Secondary Outcome Measures

Outcome Measure
Time Frame
severity of influenza symptoms
Time Frame: until 3 months gargling
until 3 months gargling
influenza-free time during the study period
Time Frame: until 3 months gargling
until 3 months gargling
incidence of complications
Time Frame: until 3 months gargling
until 3 months gargling
incidence rates of upper respiratory tract infections
Time Frame: until 3 months gargling
until 3 months gargling
incidence of days of absence from school
Time Frame: until 3 months gargling
until 3 months gargling
occurrence of the adverse events
Time Frame: until 3 months gargling
until 3 months gargling

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Shizuoka

Investigators

  • Study Chair: Hiroshi Yamada, MD, PhD, University of Shizuoka

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

October 19, 2010

First Submitted That Met QC Criteria

October 20, 2010

First Posted (Estimate)

October 21, 2010

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT2010001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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