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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027472
Receipt No. R000031471
Scientific Title Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Date of disclosure of the study information 2017/05/24
Last modified on 2020/11/25

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Basic information
Public title Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Acronym Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Scientific Title Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Scientific Title:Acronym Efficacy evaluation of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100)
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Hepato-biliary-pancreatic medicine Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Four-Dimensional Phase-Contrast Vastly Undersampled Isotropic Projection Reconstruction (PC-VIPR) enables the assessment of hemodynamics of the blood vessels.
The purpose of this study is to evaluate the efficacy of PC-VIPR for the hemodynamic assessment of intestinal tract by using daikenchuto (TU-100), and compare with conventional analysis with abdominal ultrasonography (US).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ratio of SMA flow volume at t=25 min to t=-25 min measured by US and PC-VIPR.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 State of taking daikenchuto(TU-100)
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 adults over 20 years old
2.Systolic blood pressure under 140mmHg
3.Written informed consent
Key exclusion criteria 1. Person with MRI contraindications (claustrophobic, metal in the body, etc.)
2.High blood pressure
3.The past of the heart disease
4.With the history of abdominal surgery
5.Under the medical treatment
6.Disable to keep face up position
7.Pregnant or possibly pregnant
8.Under the nursing
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyotaka Kurachi
Organization Hamamatsu University School of Medicine
Division name Surgery 2, Divisions of Gastroenterological & Vascular Surgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2279
Email kurachi1@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mayu Sakata
Organization Hamamatsu University School of Medicine
Division name Surgery 2, Divisions of Gastroenterological & Vascular Surgery
Zip code
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu, Japan
TEL 053-435-2279
Homepage URL
Email mayu-s@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2017 Year 05 Month 24 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 Completed
Date of protocol fixation
2017 Year 05 Month 11 Day
Date of IRB
2017 Year 05 Month 02 Day
Anticipated trial start date
2017 Year 05 Month 24 Day
Last follow-up date
2018 Year 04 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 24 Day
Last modified on
2020 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031471

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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