UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study on pharyngeal retention of tea catechins
Acronym	Pharyngeal retention of tea catechins
Scientific Title	Clinical study on pharyngeal retention of tea catechins
Scientific Title:Acronym	Pharyngeal retention of tea catechins
Region	Japan

Condition
Condition	None
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate local retention of pharyngeal and oral mucosa of tea catechins in humans
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Amount of catechins in the swabbing solution before and after the intake of the test product
Key secondary outcomes	Antiviral activity in the swabbing solution before and after the intake of the test product

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	1 day 57 mg tea catechins once a day
Interventions/Control_2
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	65 years-old >=
Gender	Male and Female
Key inclusion criteria	(1)Healthy adults between 20 and 65 years old (2)Able to provide written informed consent (3)Able to intake and gargle test product (4)Able to write questionnaire
Key exclusion criteria	(1)Potentially having the allergy or side effects to tea-derived components (2)Having injury or inflammation in the oral cavity or pharynx (3)Being treated for liver, kidney, heart, respiratory, endocrine or metabolic, systemic immune, systemic infectious or other diseases (4)Not able to stop taking food or supplements containing tea catechins (5)Going to participate any clinical trial other than this study (6)Judged as ineligible for this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Yamada
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
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 Daisuke Middle name Last name Furushima
Organization	University of Shizuoka
Division name	School of Pharmaceutical Sciences
Zip code	422-8526
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
TEL	+81-54-264-5591
Homepage URL	http://u-shizuoka-ken.ac.jp
Email	dfuru@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	Kao Corporation
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Shizuoka Research Ethics Committee
Address	52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan
Tel	054-264-5103
Email	rinri@u-shizuoka-ken.ac.jp

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	花王株式会社 栃木事業場(栃木県)/ Kao Corporation Tochigi Plant

Other administrative information
Date of disclosure of the study information	2019 Year 07 Month 31 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	2019 Year 07 Month 01 Day
Date of IRB	2019 Year 07 Month 01 Day
Anticipated trial start date	2019 Year 07 Month 25 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry	2019 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 07 Month 24 Day
Last modified on	2021 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042720