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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030103
Receipt No. R000034373
Scientific Title The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial
Date of disclosure of the study information 2017/11/30
Last modified on 2017/11/30

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Basic information
Public title The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial
Acronym The effects of green tea-derived components on acute upper respiratory tract inflammation
Scientific Title The effects of green tea-derived components on acute upper respiratory tract inflammation for health care workers; single-blinded randomized parallel-group trial
Scientific Title:Acronym The effects of green tea-derived components on acute upper respiratory tract inflammation
Region
Japan

Condition
Condition Acute upper respiratory tract inflammation
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effects of green tea-derived components on the development of acute upper respiratory tract inflammation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The occurrence of acute upper respiratory tract inflammation (including influenza).
Key secondary outcomes 1. Incidence of influenza like illness.
2. Frequency of acute upper respiratory tract inflammation (including influenza).
3. Adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 12 weeks,
Placebo drink,
once a day
Interventions/Control_2 12 weeks,
Active drink, including green tea-derived components,
once a day
Interventions/Control_3 12 weeks,
Active drink, including green tea-derived components,
three times a day
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
75 years-old >
Gender Male and Female
Key inclusion criteria (1) The male and female employees aged 20 or over but under 75 who work in medical and welfare facilities
(2) Able to give written informed consent
(3) Able to intake tea catechins
(4) Able to write questionnaire
Key exclusion criteria (1) Potentially having the allergy to tea-derived components
(2) Having severe systemic chronic infectious diseases
(3) Being difficulty to participate the study due to having severe hepatic/renal/ cardiac/respiratory/endocrinological/metabolic disorder, neurological and consciousness disorder, diabetes and other illnesses
(4) Having severe immune deficiency or autoimmune disease, or taking drugs influencing immune functions (e.g. steroid, immunosuppressive drugs, and so on)
(5) Not able to stop health products or supplements that potentially influence immune functions
(6) Going to participate any clinical trial
other than this study
(7) Subjects diagnosed by physicians inappropriate to participate in the study
Target sample size 300

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 422-8526, 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 422-8526, 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 Kao Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor (1) White Cross Nursing Home
(2) Tokyo White Cross Hospital
(3) Tokyo-Bannan-Hakkoen
(4) Kao-Corporation
Name of secondary funder(s)

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

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 No longer recruiting
Date of protocol fixation
2017 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 27 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 15 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 11 Month 24 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034373

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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