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Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

Primary Purpose

Influenza Infection

Status

Unknown status

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

green tea

About this trial

This is an interventional prevention trial for Influenza Infection focused on measuring green tea, gargling, prophylaxis, influenza, Respiratory Tract Infections, high school students

Eligibility Criteria

15 Years - 20 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of ShizuokaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Green tea

water

Arm Description

Gargling with green tea

Gargling with water

Outcomes

Primary Outcome Measures

the incidence rates of influenza infection

Secondary Outcome Measures

severity of influenza symptoms

influenza-free time during the study period

incidence of complications

incidence rates of upper respiratory tract infections

incidence of days of absence from school

occurrence of the adverse events

Full Information

NCT ID

NCT01225770

First Posted

October 19, 2010

Last Updated

February 12, 2013

Sponsor

University of Shizuoka

1. Study Identification

Unique Protocol Identification Number

NCT01225770

Brief Title

Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Unknown status

Study Start Date

November 2010 (undefined)

Primary Completion Date

April 2014 (Anticipated)

Study Completion Date

August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Shizuoka

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza Infection

Keywords

green tea, gargling, prophylaxis, influenza, Respiratory Tract Infections, high school students

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

640 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Green tea

Arm Type

Experimental

Arm Description

Gargling with green tea

Arm Title

water

Arm Type

Active Comparator

Arm Description

Gargling with water

Intervention Type

Dietary Supplement

Intervention Name(s)

green tea

Intervention Description

Gargling three times daily for 90 days

Primary Outcome Measure Information:

Title

the incidence rates of influenza infection

Time Frame

Until 3 months gargling

Secondary Outcome Measure Information:

Title

severity of influenza symptoms

Time Frame

until 3 months gargling

Title

influenza-free time during the study period

Time Frame

until 3 months gargling

Title

incidence of complications

Time Frame

until 3 months gargling

Title

incidence rates of upper respiratory tract infections

Time Frame

until 3 months gargling

Title

incidence of days of absence from school

Time Frame

until 3 months gargling

Title

occurrence of the adverse events

Time Frame

until 3 months gargling

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hiroshi Yamada, MD, PhD

Phone

+81-54-264-5762

hyamada@u-shizuoka-ken.ac.jp

First Name & Middle Initial & Last Name or Official Title & Degree

Keiji Matsumoto, MS

Phone

+81-54-264-5770

d10902@u-shizuoka-ken.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hiroshi Yamada, MD, PhD

Organizational Affiliation

University of Shizuoka

Official's Role

Study Chair

Facility Information:

Facility Name

University of Shizuoka

City

Shizuoka

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hiroshi Yamada, MD, PhD

Phone

+81-54-264-5762

hyamada@u-shizuoka-ken.ac.jp

First Name & Middle Initial & Last Name & Degree

Keiji Matsumoto, Ms

Phone

+81-54-264-5770

d10902@u-shizuoka-ken.ac.jp

First Name & Middle Initial & Last Name & Degree

Hiroshi Yamada, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

24836780

Citation

Ide K, Yamada H, Matsushita K, Ito M, Nojiri K, Toyoizumi K, Matsumoto K, Sameshima Y. Effects of green tea gargling on the prevention of influenza infection in high school students: a randomized controlled study. PLoS One. 2014 May 16;9(5):e96373. doi: 10.1371/journal.pone.0096373. eCollection 2014.

Results Reference

derived

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Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

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