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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000024362
Receipt No. R000028045
Scientific Title Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study
Date of disclosure of the study information 2016/10/14
Last modified on 2017/11/24

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Basic information
Public title Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study
Acronym Effects of catechin-derivative-treated masks on the prevention of influenza infection
Scientific Title Effects of catechin-derivative-treated masks on the prevention of influenza infection: an exploratory randomized study
Scientific Title:Acronym Effects of catechin-derivative-treated masks on the prevention of influenza infection
Region
Japan

Condition
Condition Influenza infection
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects catechin-derivative-treated masks on the prevention of influenza infection
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Incidence rate of influenza-like illness during the study period
Key secondary outcomes 1)Incidence rate of laboratory-confirmed influenza A or B virus infection
2)Incidence rate of laboratory-confirmed influenza infection or influenza-like illness
3)Incidence rate of acute upper respiratory tract infection
4)Mask-wearing rate
5)Incidence of adverse device effect and defect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Catechin-derivative-treated mask/60 days
Interventions/Control_2 Non-catechin-derivative-treated mask/60 days
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Written informed consent obtained before participation
2)Aged 20 years old or older
3)Opportunity to interact with influenza infected subjects
4)Willing and able to wear masks during the study period
5)Willing and able to fill out questionnaires
Key exclusion criteria 1)Green tea allergy
2)Allergy to mask material
3)Severe immune disease
4)Chronic systemic infectious disease
5)History of influenza infection within the previous 6 months and influenza infection within 24 hours after participation
6)Subjects diagnosed by a physician inappropriate to participate in the study
Target sample size 250

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Yamada
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL +81-54-264-5762
Email hyamada@u-shizuoka-ken.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Yamada
Organization University of Shizuoka
Division name School of Pharmaceutical Sciences
Zip code
Address 52-1 Yada, Suruga-ku, Shizuoka, Japan
TEL +81-54-264-5762
Homepage URL http://u-shizuoka-ken.ac.jp
Email hyamada@u-shizuoka-ken.ac.jp

Sponsor
Institute University of Shizuoka
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor White Cross Nursing Home
Osaka University
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 静岡県立大学(静岡県)/University of Shizuoka(Shizuoka)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 30 Day
Date trial data considered complete
2017 Year 08 Month 30 Day
Date analysis concluded
2017 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 10 Month 11 Day
Last modified on
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028045

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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