UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027472 |
|---|---|
| Receipt number | 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 09:38:23 |
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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
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
mayu-s@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031471
