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Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

This study is currently recruiting participants.
Verified February 2013 by University of Shizuoka
Sponsor:
Information provided by (Responsible Party):
University of Shizuoka
ClinicalTrials.gov Identifier:
NCT01225770
First received: October 19, 2010
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Influenza Infection
 Dietary Supplement: green tea
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Gargling With Green Tea on Preventing Influenza Infection Among High School Students: A Randomized Clinical Study

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by University of Shizuoka:

Primary Outcome Measures:
  • the incidence rates of influenza infection [ Time Frame: Until 3 months gargling ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • severity of influenza symptoms [ Time Frame: until 3 months gargling ] [ Designated as safety issue: No ]
  • influenza-free time during the study period [ Time Frame: until 3 months gargling ] [ Designated as safety issue: No ]
  • incidence of complications [ Time Frame: until 3 months gargling ] [ Designated as safety issue: No ]
  • incidence rates of upper respiratory tract infections [ Time Frame: until 3 months gargling ] [ Designated as safety issue: No ]
  • incidence of days of absence from school [ Time Frame: until 3 months gargling ] [ Designated as safety issue: No ]
  • occurrence of the adverse events [ Time Frame: until 3 months gargling ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 640
Study Start Date: November 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   15 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01225770

Contacts
Contact: Hiroshi Yamada, MD, PhD +81-54-264-5762 hyamada@u-shizuoka-ken.ac.jp
Contact: Keiji Matsumoto, MS +81-54-264-5770 d10902@u-shizuoka-ken.ac.jp

Locations
Japan
University of Shizuoka Recruiting
Shizuoka, Japan
Contact: Hiroshi Yamada, MD, PhD     +81-54-264-5762     hyamada@u-shizuoka-ken.ac.jp    
Contact: Keiji Matsumoto, Ms     +81-54-264-5770     d10902@u-shizuoka-ken.ac.jp    
Principal Investigator: Hiroshi Yamada, MD, PhD            
Sponsors and Collaborators
University of Shizuoka
Investigators
Study Chair: Hiroshi Yamada, MD, PhD University of Shizuoka
  More Information

No publications provided

Responsible Party: University of Shizuoka
ClinicalTrials.gov Identifier: NCT01225770     History of Changes
Other Study ID Numbers: CT2010001
Study First Received: October 19, 2010
Last Updated: February 12, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Shizuoka:
green tea
gargling
prophylaxis
 influenza
Respiratory Tract Infections
high school students

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
 Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 21, 2013