UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003690 |
|---|---|
| Receipt number | R000004469 |
| Scientific Title | The examination of efficacy of the Japanese herbal medicine (Inchin-ko-to) in preventing postoperative liver dysfunction after major hepatectomy. |
| Date of disclosure of the study information | 2010/06/01 |
| Last modified on | 2012/06/01 21:42:17 |
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Basic information
Public title
The examination of efficacy of the Japanese herbal medicine (Inchin-ko-to) in preventing postoperative liver dysfunction after major hepatectomy.
Acronym
The examination of efficacy of Inchin-ko-to.
Scientific Title
The examination of efficacy of the Japanese herbal medicine (Inchin-ko-to) in preventing postoperative liver dysfunction after major hepatectomy.
Scientific Title:Acronym
The examination of efficacy of Inchin-ko-to.
Region
| Japan |
Condition
Condition
Biliary tract carcinoma
Hepatocellular carcinoma
Metastatic liver carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To examine the effect of Inchin-ko-to in preventing postoperative liver dysfunction following major hepatectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative liver dysfunction and
other complications
Key secondary outcomes
The Level of inflammatory cytokines and iNOS in the expected remnant liver.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Inchin-ko-to(Tsumura,Japan;7.5g/day)
Interventions/Control_2
Control: 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
Patients who fulfilled the criteria and agreed with the enrollment in this study.
Key exclusion criteria
Patients who reject to be enrolled in this study.
Patients who do not fulfill the criteria of this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Nagino |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL
052-744-2222
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukihiro Yokoyama |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya, Aich
TEL
052-744-2222
Homepage URL
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2010 | Year | 06 | 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
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 06 | Month | 01 | Day |
Last modified on
| 2012 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004469
