UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015486 |
|---|---|
| Receipt number | R000012077 |
| Scientific Title | Effects for intestinal blood flow and neuropeptide hormone in the patients of cerebrovascular disorder with constipation by thermal stimulation on the abdomen |
| Date of disclosure of the study information | 2014/10/22 |
| Last modified on | 2017/10/23 09:12:35 |
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Basic information
Public title
Effects for intestinal blood flow and neuropeptide hormone in the patients of cerebrovascular disorder with constipation by thermal stimulation on the abdomen
Acronym
Effects of thermal stimulation on the abdomen in the patients of cerebrovascular disorder with constipation
Scientific Title
Effects for intestinal blood flow and neuropeptide hormone in the patients of cerebrovascular disorder with constipation by thermal stimulation on the abdomen
Scientific Title:Acronym
Effects of thermal stimulation on the abdomen in the patients of cerebrovascular disorder with constipation
Region
| Japan |
Condition
Condition
patients of cerebrovascular disorder with constipation
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Geriatrics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects for intestinal blood flow and neuropeptide hormone in the patients of cerebrovascular disorder with constipation by thermal stimulation on the abdomen
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
increase of blood flow in the superior mesenteric artery
Key secondary outcomes
increase of neuropeputide hormone associated with bowel movement
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
| Device,equipment |
Interventions/Control_1
abdominal thermal stimulation
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
| 40 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
over 1 year past after cerebro-vascular disorder
with the symptom of constipation and the Roma III category shows functional constipation
without aphasia
withour cognitive dysfunction or with mild cognitive dysfunction who can explain their conditions
stable state
acquisition of written informed consent
Key exclusion criteria
with the condition of malignancy, intestinal adhesion, and inflamatory bowel syndrome
unstable condition
cannot communicate enough
with aphasia
cannot explain their conditions because of cognitive dysfunction
with pregnancy
with a necessity of consideration for a name of disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Takayama |
Organization
Graduate school of medicine, Tohoku University
Division name
Comprehensive Education Center for Community Medicine
Zip code
Address
2-1, Seiryomachi, Aobaku, Sendai city, Miyagi prefecture
TEL
022-717-7507
takayama@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Takayama |
Organization
Graduate school of medicine, Tohoku University
Division name
Comprehensive Education Center for Community Medicine
Zip code
Address
2-1, Seiryomachi, Aobaku, Sendai city, Miyagi prefecture
TEL
022-717-7507
Homepage URL
takayama@med.tohoku.ac.jp
Sponsor or person
Institute
Graduate school of medicine, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research (C)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2014 | Year | 10 | Month | 22 | 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
Suspended
Date of protocol fixation
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 21 | Day |
Last modified on
| 2017 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012077
