UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045333 |
|---|---|
| Receipt number | R000051770 |
| Scientific Title | Observational studies assessing the effects of Buddhist training on the mental and intestinal flora |
| Date of disclosure of the study information | 2022/08/31 |
| Last modified on | 2021/09/01 08:54:09 |
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Basic information
Public title
Observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Acronym
Observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Scientific Title
Observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Scientific Title:Acronym
Observational studies assessing the effects of Buddhist training on the mental and intestinal flora
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of Buddhist training on the mental and intestinal flora of Buddhist practitioners.
Basic objectives2
Others
Basic objectives -Others
Evaluate the effects of Buddhist training on the mental and intestinal flora of Buddhist practitioners.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. intestinal flora
2. Anxiety and sleep questionnaire
Key secondary outcomes
1. Oral flora
2. Skin flora
3. Skin-related marker
4. Facial expression-related marker
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Buddhist training participants
2. Healthy male
Key exclusion criteria
1. Minors
2. Cannot complete Buddhist training
3. Those suffering from serious illness
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Miyazaki |
Organization
Asahi quality and innovations, Ltd
Division name
Core technology laboratories
Zip code
302-0106
Address
1-21, Midori 1-Chome, Moriya-shi, Ibaraki
TEL
0297-46-9498
hidetoshi.miyazaki@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Miyazaki |
Organization
Asahi quality and innovations, Ltd
Division name
Core technology laboratories
Zip code
302-0106
Address
1-21, Midori 1-Chome, Moriya-shi, Ibaraki
TEL
0297-46-9498
Homepage URL
hidetoshi.miyazaki@asahi-qi.co.jp
Sponsor or person
Institute
Asahi quality and innovations, Ltd
Institute
Department
Personal name
Funding Source
Organization
Asahi quality and innovations, 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
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku-ku, Tokyo
Tel
03-6704-5968
n-yuzawa@imeqrd.co.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
高野山専修学院（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 08 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
To clarify the effects of Buddhist training on the mental and intestinal flora
Management information
Registered date
| 2021 | Year | 09 | Month | 01 | Day |
Last modified on
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051770
