UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009829 |
|---|---|
| Receipt number | R000011516 |
| Scientific Title | The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI |
| Date of disclosure of the study information | 2013/01/21 |
| Last modified on | 2013/01/21 22:31:41 |
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Basic information
Public title
The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI
Acronym
The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI
Scientific Title
The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI
Scientific Title:Acronym
The efiicacy and safety of Rikkunshito for nausea and appetite loss in the treatment for HCC by TAI
Region
| Japan |
Condition
Condition
HCC
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the efficay of Rikkunshito for nausea and appetite loss in the treatment of HCC
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of nausea and appetite loss
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Rikkunshito
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HCC who are treated by TAI
Key exclusion criteria
It depends on Physician's dicision
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Yokosuka |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
Address
TEL
043-226-2083
Homepage URL
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Tsumura Co.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 01 | Month | 21 | 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
| 2007 | Year | 03 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | 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
| 2013 | Year | 01 | Month | 21 | Day |
Last modified on
| 2013 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011516
