Catechin Gargling for Influenza Infection

Influenza Infection Clinical Trial

Official title:

A Randomized Clinical Study of Catechin Gargling Effects on the Prevention of Influenza Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00239213
• Other study ID #: CT2005002
• Status: Completed
• Phase: N/A
• First received: October 13, 2005
• Last updated: October 28, 2006
• Start date: November 2005
• Est. completion date: April 2006

Study information

• Verified date: October 2006
• Source: University of Shizuoka
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to clarify the preventive effects of catechin gargling on the influenza infection.

Description:

In-vitro experimental studies have revealed that tea catechin extracts induce preventive effects on influenza infection. However, few studies have been conducted on the effects of tea gargling on influenza infection, and the clinical evidence is unclear. Also there have been no studies reported on the gargling effects with tea catechin extracts on the prevention of influenza infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• healthy volunteers

• aged 20 to 65 years old

• obtained written informed concent before participation

• inoculated with influenza vaccine before entering the study

Exclusion Criteria:

• other gargling except water during the study

• possessing tea allergy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Influenza Infection
• Influenza, Human

Intervention

Drug:
• catechin extracts (health food)

Locations

Country	Name	City	State
Japan	Seirei Hamamatsu General Hospital	Hamamatsu	Shizuoka
Japan	White Cross Nursing Home	Higashi Murayama	Tokyo
Japan	Shizuoka General Hospial	Shizuoka

Sponsors (4)

Lead Sponsor	Collaborator
University of Shizuoka	Seirei Hamamatsu General Hospital, Shizuoka General Hospital, White Cross Nursing Home

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rates of influenza infection during the study
Secondary	severity of symptoms including complications and hospitalization