Catechin Containing Mask for the Prevention of Influenza... | NCT00812448

Studies
Catechin Containing Mask for the Prevention of Influenza Infection

NCT00812448

Sponsor

University of Shizuoka

Status

Completed

Last Update Posted

Nov 26, 2009Estimated

Enrollment

180Actual

Phase

Not Applicable

Conditions

Influenza Infection

Interventions

tea catechin extracts

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
20-24

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Dec 18, 2008

First Submission Date that Met QC Criteria

Dec 19, 2008

First Posted Date

Dec 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 24, 2009

Last Update Posted Date

Nov 26, 2009Estimated

Name	Class
Seirei Hamamatsu General Hospital	OTHER
Hamamatsu University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effects of catechin extracts containing mask on prevention of influenza infection.

Detailed Description

Catechins are the major components of tea flavonoids and are reported to possess physiological activities such as antiviral effects. Recent in-vitro experimental studies have revealed that tea catechin extracts possess the effects on the prevention of influenza infection. However, a limited number of studies have been conducted on the clinical effects. Based on these backgrounds, we designed a prospective randomized controlled study to evaluate the effects of tea catechin extracts containing mask on the prevention of influenza infection.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tea catechin extracts containing mask	Experimental	wearing the tea catechin extracts containing mask	Dietary Supplement: tea catechin extracts

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tea catechin extracts	Dietary Supplement	catechins are composed of tea catechin extracts available in grren tea supplements	tea catechin extracts containing mask

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the incidence rate of influenza infection during the study		assessed at each month

Secondary Outcomes

Measure	Description	Time Frame
the incidence rates of upper respiratory tract infections		assessed at each month
the severity of the symptoms and the duration of the cold among incident cases		assessed at each month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Possible to wearing mask for three months
Possible to fill out a questionnaire personally
Obtained written informed consent before participation

Exclusion Criteria:

Possessing some infectious diseases in need of therapy
Possessing tea or catechin allergy
diagnosed as inadequate for other reasons to participate the study by principal investigator

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hiroshi Yamada, MD,PhD	University of Shizuoka	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seirei Hamamatsu General Hospital		Hamamatsu	Shizuoka		Japan
University of Shizuoka