UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048887 |
|---|---|
| Receipt number | R000055706 |
| Scientific Title | Analysis of gastric migrating motor complexes using pick up |
| Date of disclosure of the study information | 2022/09/08 |
| Last modified on | 2022/09/08 15:52:49 |
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Basic information
Public title
Analysis of gastric migrating motor complexes using pick up
Acronym
Analysis of gastric migrating motor complexes using pick up
Scientific Title
Analysis of gastric migrating motor complexes using pick up
Scientific Title:Acronym
Analysis of gastric migrating motor complexes using pick up
Region
| Japan |
Condition
Condition
healy body
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to establish a method to capture gastric movements during the fasting and postprandial phases from intestinal sounds using pick up, and to objectively clarify human MMC.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cyclic Measurements-counter
Key secondary outcomes
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
After establishing a method to detect gastric motility in the fasting and postprandial phases based on bowel sounds using pick up, acupuncture intervention is used to confirm changes in gastric motility.
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
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
healthy body
Key exclusion criteria
Have diabetes and/or gastrointestinal related diseases or pre-existing conditions (including functional dyspepsia and IBS). Have a history of physical discomfort with or without food (e.g., fasting, dieting, etc.). Those who are not aware of hunger gluttony in daily life.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Taniguchi |
Organization
Tokyo Ariake University of Medical Science
Division name
Department of Acupuncture and Moxibustion, Faculty of Health and Medical Care
Zip code
1350063
Address
2-9-1 Ariake ,Koto-ku, Tokyo
TEL
0367037000
maki985@msn.com
Public contact
Name of contact person
| 1st name | Maki |
| Middle name | |
| Last name | Furube |
Organization
Tokyo Ariake University of Medical Science
Division name
Department of Acupuncture and Moxibustion, Faculty of Health and Medical Care
Zip code
1350063
Address
2-9-1 Ariake ,Koto-ku, Tokyo
TEL
0367037000
Homepage URL
maki985@msn.com
Sponsor or person
Institute
Tokyo Ariake University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Tokyo Ariake University of Medical Science
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
Tokyo Ariake University of Medical Science
Address
2-9-1 Ariake ,Koto-ku, Tokyo
Tel
0367037000
maki985@msn.com
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
| 2022 | Year | 09 | Month | 08 | 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
| 2022 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 01 | 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
| 2022 | Year | 09 | Month | 08 | Day |
Last modified on
| 2022 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055706
| Research Plan | |
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| 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 |
