UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020713 |
|---|---|
| Receipt number | R000023642 |
| Scientific Title | The antispasmodic effective of shakuyaku-kanzo-to(TJ-68) on the colonic wall by direct spraying:a randomized controlled prospective study |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2017/07/26 11:48:51 |
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Basic information
Public title
The antispasmodic effective of shakuyaku-kanzo-to(TJ-68) on the colonic wall by direct spraying:a randomized controlled prospective study
Acronym
Shakuyaku-kanzo-to(TJ-68) for the colonoscopy
Scientific Title
The antispasmodic effective of shakuyaku-kanzo-to(TJ-68) on the colonic wall by direct spraying:a randomized controlled prospective study
Scientific Title:Acronym
Shakuyaku-kanzo-to(TJ-68) for the colonoscopy
Region
| Japan |
Condition
Condition
The over twenty years old patient perform the large intestine endoscopy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine after three minute late
Key secondary outcomes
The background of patient and the time of the prevention of colonic spasm when spraying the shakuyaku-kannzoutou in the large intestine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
shakuyaku-kanzoutou 5.0g in the 50ml saline of 36celsius
Interventions/Control_2
the 50ml saline of 36celsius
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 pacient of performed the colonoscopy
Key exclusion criteria
the pacient has the allergy of shakuyaku-kannzoutou.
the pacient has the aldosteronism.
the pacient has the myopathy.
the pacient has the hypokalemia.
the pacient of post operation.
tha pacient has IBD.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuki okamoto |
Organization
Kinki University School of Medicine
Division name
Department of gastroenterology and Hepatology
Zip code
Address
377-2onohigashi osakasayama-shi osaka-hu
TEL
072-366-0221
kazukiokamoto815@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimiko Yuge |
Organization
Kinki University School of Medicine
Division name
Department of gastroenterology and Hepatology
Zip code
Address
377-2onohigashi osakasayama-shi osaka-hu
TEL
072-366-0221
Homepage URL
kin-live@med.kindai.ac.jp
Sponsor or person
Institute
Kinki University School of Medicine,Department of gastroenterology and Hepatology
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
| 2016 | Year | 01 | Month | 25 | 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
| 2016 | Year | 01 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 15 | 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
| 2016 | Year | 01 | Month | 23 | 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=R000023642
