UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046498 |
|---|---|
| Receipt number | R000053034 |
| Scientific Title | Study on the synergistic effect of zazen and tea |
| Date of disclosure of the study information | 2021/12/28 |
| Last modified on | 2024/07/01 10:49:49 |
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Basic information
Public title
Effects of the interaction of Zazen and tea
Acronym
The Interaction of Zazen and Tea
Scientific Title
Study on the synergistic effect of zazen and tea
Scientific Title:Acronym
Synergistic effect of zazen and tea
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examine the synergistic effects of Zazen and green tea
Basic objectives2
Others
Basic objectives -Others
Tests aimed at evaluating synergistic effects
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Autonomic function before, during, and after the intervention
Key secondary outcomes
Mood and emotions before and after the intervention
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food | Behavior,custom |
Interventions/Control_1
green tea,zazen
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy ordinary people
Key exclusion criteria
People with arrhythmias
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Honda |
Organization
Shizuoka University of Welfare
Division name
Faculty of Social Welfare
Zip code
425-8611
Address
549-1Honnakane,Yaizu-city,shizuoka425-8611,Japan
TEL
054-623-7451
s_honda@suw.ac.jp
Public contact
Name of contact person
| 1st name | Shoko |
| Middle name | |
| Last name | Honda |
Organization
Shizuoka University of Welfare
Division name
Faculty of Social Welfare
Zip code
425-8611
Address
549-1Honnakane,Yaizu-city,shizuoka425-8611,Japan
TEL
054-623-7451
Homepage URL
s_honda@suw.ac.jp
Sponsor or person
Institute
Shizuoka University of Welfare
Institute
Department
Personal name
Funding Source
Organization
ITO EN,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka University of Welfare
Address
549-1Honnakane,Yaizu-city,shizuoka425-8611,Japan
Tel
054-623-7451
s_honda@suw.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
| 2021 | Year | 12 | Month | 28 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The results have not been published yet.
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
| 2021 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053034
