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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031037
Receipt No. 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

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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
Email 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
Email uetsuki@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Anesthsia, Kyoto University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035377

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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