NCT00239213

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2005

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 14, 2005

Completed
18 days until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

October 31, 2006

Status Verified

October 1, 2006

First QC Date

October 13, 2005

Last Update Submit

October 28, 2006

Conditions

Influenza Infection

Keywords

catechinsgarglinghealthy volunteers

Outcome Measures

Primary Outcomes (1)

  • Incidence rates of influenza infection during the study

Secondary Outcomes (1)

  • severity of symptoms including complications and hospitalization

Interventions

catechin extracts (health food)DRUG

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy volunteers
  • aged 20 to 65 years old
  • obtained written informed concent before participation
  • inoculated with influenza vaccine before entering the study

You may not qualify if:

  • other gargling except water during the study
  • possessing tea allergy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seirei Hamamatsu General Hospital

Hamamatsu, Shizuoka, 430-8558, Japan

Location

Shizuoka General Hospial

Shizuoka, Shizuoka, 420-8527, Japan

Location

White Cross Nursing Home

Higashimurayama, Tokyo, 189-0021, Japan

Location

Study Officials

  • Hiroshi Yamada, MD, PhD

    University of Shizuoka

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 14, 2005

Study Start

November 1, 2005

Study Completion

April 1, 2006

Last Updated

October 31, 2006

Record last verified: 2006-10

Locations

JP(3)