Gargling With Green Tea for Prophylaxis of Influenza Infection in Teenagers

Study Overview
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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.

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

Conditions
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Influenza Infection

Intervention / Treatment
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* Dietary Supplement: green tea


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Green tea<br>Gargling with green tea | Dietary Supplement: green tea<br>* Gargling three times daily for 90 days<br>|
| Active Comparator: water<br>Gargling with water | Dietary Supplement: green tea<br>* Gargling three times daily for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence rates of influenza infection |  | Until 3 months gargling | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| occurrence of the adverse events |  | until 3 months gargling | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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green tea, gargling, prophylaxis, influenza, Respiratory Tract Infections, high school students