Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

NCT ID: NCT01225770

Last Updated: 2013-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

640 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-08-31

Brief Summary

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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

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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.

Conditions

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Influenza Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Green tea

Gargling with green tea

Group Type EXPERIMENTAL

green tea

Intervention Type DIETARY_SUPPLEMENT

Gargling three times daily for 90 days

water

Gargling with water

Group Type ACTIVE_COMPARATOR

green tea

Intervention Type DIETARY_SUPPLEMENT

Gargling three times daily for 90 days

Interventions

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green tea

Gargling three times daily for 90 days

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Shizuoka

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hiroshi Yamada, MD, PhD

Role: STUDY_CHAIR

University of Shizuoka

Locations

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University of Shizuoka

Shizuoka, Shizuoka, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Hiroshi Yamada, MD, PhD

Role: CONTACT

+81-54-264-5762

Keiji Matsumoto, MS

Role: CONTACT

+81-54-264-5770

Facility Contacts

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Hiroshi Yamada, MD, PhD

Role: primary

+81-54-264-5762

Keiji Matsumoto, Ms

Role: backup

+81-54-264-5770

References

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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.

Reference Type DERIVED
PMID: 24836780 (View on PubMed)

Other Identifiers

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CT2010001

Identifier Type: -

Identifier Source: org_study_id

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