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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000037474
Receipt No. R000042720
Scientific Title Clinical study on pharyngeal retention of tea catechins
Date of disclosure of the study information 2019/07/31
Last modified on 2020/02/17

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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 No longer recruiting
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
2020 Year 02 Month 17 Day


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

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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