UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004673 |
|---|---|
| Receipt number | R000005567 |
| Scientific Title | Effect of daikenchuto for the decrease of colon diverticulum |
| Date of disclosure of the study information | 2010/12/08 |
| Last modified on | 2020/06/27 21:15:33 |
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Basic information
Public title
Effect of daikenchuto for the decrease of colon diverticulum
Acronym
Effect of daikenchuto for the decrease of colon diverticulum
Scientific Title
Effect of daikenchuto for the decrease of colon diverticulum
Scientific Title:Acronym
Effect of daikenchuto for the decrease of colon diverticulum
Region
| Japan |
Condition
Condition
colon diverticulosis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We stutdy that the effect of daikentyuto for the decrease of colon diverticulum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The disappearance or decrease of colon diverticulum
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Daikenchuto
Interventions/Control_2
no treatment
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 one with a lower gut symptom among 20-year-old or more cases from whom the diverticulum of colon was admitted by the roentgenologic examination.
Key exclusion criteria
The patient who collides with either the following assumes that it doesn't put it in to the examination
1) Drug allergy
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Inamori |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterology Division
Zip code
Address
3-9 Fuku-ura, Kanagawa-ku, Yokohama, Japan
TEL
045-787-2640
Homepage URL
inamorim@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterology Division, Yokohama City University Graduate School of Medicine
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
横浜市立大学附属病院（神奈川県）、たらお内科・消化器科（神奈川県）、横浜市立大学附属病院市民医療センター（神奈川県）、岐阜市民病院（岐阜県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 08 | 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
| 2010 | Year | 12 | Month | 08 | Day |
Date of IRB
| 2011 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2020 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005567
