UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050205 |
|---|---|
| Receipt number | R000057161 |
| Scientific Title | Verification of the Effect of Environment of "the Way of Tea" on the Body. |
| Date of disclosure of the study information | 2023/01/31 |
| Last modified on | 2024/03/10 17:11:36 |
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Basic information
Public title
Verification of the Effect of Environment of "the Way of Tea" on the Body.
Acronym
Verification of the Effect of Environment of "the Way of Tea" on the Body.
Scientific Title
Verification of the Effect of Environment of "the Way of Tea" on the Body.
Scientific Title:Acronym
Verification of the Effect of Environment of "the Way of Tea" on the Body.
Region
| Japan |
Condition
Condition
Normal healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the effects of "the Way of Tea" environment on the body based on physiological data of healthy men and women.
Basic objectives2
Others
Basic objectives -Others
.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Outcome Name: heart rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
For research subjects, clinical data are collected using medical equipment. We perform randomization as a crossover design.
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
| 18 | years-old | <= |
Age-upper limit
| 39 | years-old | > |
Gender
Male and Female
Key inclusion criteria
This study targets healthy adults.
Key exclusion criteria
Those who are pregnant, Mental illness, Arrhythmia, Diabetes or autonomic nervous system disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | TOMOHIKO |
| Middle name | |
| Last name | NAKAMURA |
Organization
Hamamatsu University Hospital
Division name
Neurology
Zip code
431-3125
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2111
tomohiko@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | HISAE |
| Middle name | |
| Last name | MINAMI |
Organization
Hamamatsu University School of Medicine
Division name
Neurology
Zip code
431-3125
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
TEL
053-435-2111
Homepage URL
h.minami.596@nitech.jp
Sponsor or person
Institute
Hamamatu University School of medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatu University School of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee for Life Science and Medical Research, Hamamatsu University School of Medicine
Address
1-20-1, Handayama, Chuo-ku, Hamamatsu, Shizuoka
Tel
053-435-2111
rinri@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 31 | Day |
Last modified on
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057161
| 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 |
