UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019188 |
|---|---|
| Receipt number | R000022169 |
| Scientific Title | Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/07/26 11:49:30 |
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Basic information
Public title
Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Acronym
Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Scientific Title
Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Scientific Title:Acronym
Comparing Shakuyaku-kanzo-to(TJ-68) with Minclea on the colonic wall by direct spraying
Region
| Japan |
Condition
Condition
colonoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstration Shakuyaku-kanzo-to(TJ-68) and Minclea on the colonic wall by direct spraying
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Colonic wall movementis judgment to the score. After spraying medicine decreasing score is effective
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Shakuyaku-kanzo-to(TJ-68)5.0g+saline50ml
Interventions/Control_2
Minclea20ml
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
The patient agree with this study.
Key exclusion criteria
The patient is judgmented that unsuitable for this study.
The patient has allergy to the medicine,primary aldosteronism,myopathy,hypokalemia,post operation of colon,inflammatory bowel diseases.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki okamoto |
Organization
Kinki University Hospital,Faculty of medichine
Division name
Gastroenterology
Zip code
Address
377-2onohigashiosakasayamashiosakahu
TEL
072-366-0221
hepa-gas@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Yuge |
Organization
Gastroenterology
Division name
a medical office
Zip code
Address
377-2onohigashiosakasayamashiosakahu
TEL
072-366-0221
Homepage URL
kin-live@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Hospital,Faculty of medichine Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 10 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | 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
| 2015 | Year | 10 | Month | 01 | Day |
Last modified on
| 2017 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022169
