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Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

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ClinicalTrials.gov Identifier: NCT01225770
Recruitment Status : Unknown
Verified February 2013 by University of Shizuoka.
Recruitment status was:  Recruiting
First Posted : October 21, 2010
Last Update Posted : February 15, 2013
Information provided by (Responsible Party):
University of Shizuoka

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.

Condition or disease Intervention/treatment Phase
Influenza Infection Dietary Supplement: green tea Phase 3

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  (Clinical Trial)
Estimated Enrollment : 640 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2010
Estimated Primary Completion Date : April 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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

Primary Outcome Measures :
  1. the incidence rates of influenza infection [ Time Frame: Until 3 months gargling ]

Secondary Outcome Measures :
  1. severity of influenza symptoms [ Time Frame: until 3 months gargling ]
  2. influenza-free time during the study period [ Time Frame: until 3 months gargling ]
  3. incidence of complications [ Time Frame: until 3 months gargling ]
  4. incidence rates of upper respiratory tract infections [ Time Frame: until 3 months gargling ]
  5. incidence of days of absence from school [ Time Frame: until 3 months gargling ]
  6. occurrence of the adverse events [ Time Frame: until 3 months gargling ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225770

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Shizuoka
ClinicalTrials.gov Identifier: NCT01225770     History of Changes
Other Study ID Numbers: CT2010001
First Posted: October 21, 2010    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013

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

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