UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031037 |
|---|---|
| Receipt number | R000035377 |
| Scientific Title | Exploratory study for objective evaluation of diagnostic sphygmopalpation using radial artery pulse wave meter |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2019/02/26 20:38:53 |
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Basic information
Public title
Exploratory study for objective evaluation of diagnostic sphygmopalpation using radial artery pulse wave meter
Acronym
Objective evaluation of diagnostic sphygmopalpation
Scientific Title
Exploratory study for objective evaluation of diagnostic sphygmopalpation using radial artery pulse wave meter
Scientific Title:Acronym
Objective evaluation of diagnostic sphygmopalpation
Region
| Japan |
Condition
Condition
adult healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of evidence for Kampo medicine diagnosis
Basic objectives2
Others
Basic objectives -Others
Objective evaluation for diagnostic sphygmopalpation using radial artery pulse wave meter in adult healthy volunteer
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation for the change of radial artery pulse wave before and after oral water loading
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
oral water loading
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.healthy volunteer over 20 years old
2.Those who agree participation by the document of the present study was obtained
Key exclusion criteria
1.Those who have severe disease
2.Those who was judged inappropriate by researchers
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuo Uetsuki |
Organization
Kyoto University Hospital
Division name
Department of Anesthesia
Zip code
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3111
uetsuki@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuo Uetsuki |
Organization
Kyoto University Hospital
Division name
Department of Anesthsia
Zip code
Address
54 Kawaharacho, Syogoin, Sakyo-ku, Kyoto City
TEL
075-751-3111
Homepage URL
uetsuki@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Anesthsia, Kyoto University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tsumura Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
京都大学医学部附属病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 10 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 10 | Month | 26 | Day |
Date of closure to data entry
| 2018 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 22 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 29 | Day |
Last modified on
| 2019 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035377
