UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018436 |
|---|---|
| Receipt number | R000021339 |
| Scientific Title | Impact of Rikkunshito administration on gastrointestinal function after major hepatectomy |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2019/05/18 16:17:28 |
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Basic information
Public title
Impact of Rikkunshito administration on gastrointestinal function after major hepatectomy
Acronym
Impact of Rikkunshito administration on gastrointestinal function after major hepatectomy
Scientific Title
Impact of Rikkunshito administration on gastrointestinal function after major hepatectomy
Scientific Title:Acronym
Impact of Rikkunshito administration on gastrointestinal function after major hepatectomy
Region
| Japan |
Condition
Condition
hepatectomy patients
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
analysis of Rikkunshito administration for paralysis of intestine after major hepatectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of gastrointestinal disorder
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rikkunshito 2.5g, 3 times per day
6 months administration
Interventions/Control_2
control
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Major hepatectomy patients
2.Performance Status 0 or 2
3.Patients capable of per os
4.over 20years old and under 85years old
Key exclusion criteria
1.Patients of emergency operation
2.Patients who underwent gastrectomy
3.Patients who underwent colectomy simultaneously
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Hirakata |
Organization
Nippon Medical School, Tamanagayama hospital
Division name
Department of surgery
Zip code
Address
1-7-1, Nagayama, Tama, Tokyo, 206-8512, Japan
TEL
042-371-2111
hirakata@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Hirakata |
Organization
Nippon Medical School, Tamanagayama hospital
Division name
Department of surgery
Zip code
Address
1-7-1, Nagayama, Tama, Tokyo, 206-8512, Japan
TEL
042-371-2111
Homepage URL
hirakata@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School, Tamanagayama hospital, Department of surgery
Institute
Department
Personal name
Funding Source
Organization
Nippon Medical School, Tamanagayama hospital, Department of surgery
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
| 2015 | Year | 07 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 27 | Day |
Last modified on
| 2019 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021339
