UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003475 |
|---|---|
| Receipt number | R000004205 |
| Scientific Title | The effect of BCAA enriched nutritional management for QOL and subjective symptom with liver cirrhosis. |
| Date of disclosure of the study information | 2010/04/12 |
| Last modified on | 2010/04/11 12:07:22 |
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Basic information
Public title
The effect of BCAA enriched nutritional management for QOL and subjective symptom with liver cirrhosis.
Acronym
Management of subjective symptom and QOL with liver cirrhosis
Scientific Title
The effect of BCAA enriched nutritional management for QOL and subjective symptom with liver cirrhosis.
Scientific Title:Acronym
Management of subjective symptom and QOL with liver cirrhosis
Region
| Japan |
Condition
Condition
Liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usefulness of BCAA enriched nutritional management for QOL(quality of life) and subjective symptom with liver cirrhosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of subjective symptom and QOL.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Outpatients who are stable with HCC and who will not be in a hospital in the near future:
Who had treatment for HCC more than 2 weeks ago.
Who had treatment for varix more than 2 weeks ago.
The case with complication of liver cancer is included.
Key exclusion criteria
A patient during interferon medical treatment
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Shiraki |
Organization
Gifu university
Division name
Gastroenterology
Zip code
Address
1-1, Yanagido, Gifu city, Gifu, 501-1193
TEL
(058)230-111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Gifu university
Division name
Gastroenterology
Zip code
Address
TEL
058-230-6308
Homepage URL
Sponsor or person
Institute
Gifu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
岐阜大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 12 | 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
During case entries
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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
During case entries
Management information
Registered date
| 2010 | Year | 04 | Month | 11 | Day |
Last modified on
| 2010 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004205
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
