Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers
Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study
1 other identifier
interventional
640
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2010
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 19, 2010
CompletedFirst Posted
Study publicly available on registry
October 21, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 15, 2013
February 1, 2013
3.4 years
October 19, 2010
February 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the incidence rates of influenza infection
Until 3 months gargling
Secondary Outcomes (6)
severity of influenza symptoms
until 3 months gargling
influenza-free time during the study period
until 3 months gargling
incidence of complications
until 3 months gargling
incidence rates of upper respiratory tract infections
until 3 months gargling
incidence of days of absence from school
until 3 months gargling
- +1 more secondary outcomes
Study Arms (2)
Green tea
EXPERIMENTALGargling with green tea
water
ACTIVE COMPARATORGargling with water
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Shizuoka
Shizuoka, Shizuoka, Japan
Related Publications (1)
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.
PMID: 24836780DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hiroshi Yamada, MD, PhD
University of Shizuoka
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 19, 2010
First Posted
October 21, 2010
Study Start
November 1, 2010
Primary Completion
April 1, 2014
Study Completion
August 1, 2014
Last Updated
February 15, 2013
Record last verified: 2013-02