UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2017 Year 06 Month 30 Day
Date of IRB	2017 Year 08 Month 18 Day
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	2021 Year 08 Month 10 Day

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