UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037474 |
|---|---|
| Receipt number | R000042720 |
| Scientific Title | Clinical study on pharyngeal retention of tea catechins |
| Date of disclosure of the study information | 2019/07/31 |
| Last modified on | 2021/11/15 15:52:11 |
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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
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
dfuru@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
