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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000398
Receipt No. R000000487
Scientific Title Evaluation of nutrition, immunology and QOL of the patients with liver cirrhosis by administration of oral amino-acid agent and nutritional care
Date of disclosure of the study information 2012/04/01
Last modified on 2015/08/30

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Basic information
Public title Evaluation of nutrition, immunology and QOL of the patients with liver cirrhosis by administration of oral amino-acid agent and nutritional care
Acronym GLSG, 2006, nutrition
Scientific Title Evaluation of nutrition, immunology and QOL of the patients with liver cirrhosis by administration of oral amino-acid agent and nutritional care
Scientific Title:Acronym GLSG, 2006, nutrition
Region
Japan

Condition
Condition Liver Cirrhosis
Classification by specialty
Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate nutrition, immunnity and QOL of the patients with liver cirrhosis by administration of oral amino-acid agent
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes cell immunity
Key secondary outcomes morbidity
safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 aminolevan EN
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
20 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria Liver cirrhosis (child B)
the patients with insufficient elevation of serum albumin value by administration of BCAA granules
Key exclusion criteria the patients with
regularly administration of albumin,
administration of other oral amino-acid agents,
renal dysfunction,
congenital amino-acid metabolic dysfunction,
cirrhosis by autoimmune mechanism,
scheduled treatment of varices within 3 months, with
uncontrollable ascites
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa, Maebashi, Gunma 371-8511
TEL 027-220-8127
Email satoken@gunma-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Sato
Organization Gunma University Graduate School of medicine
Division name Department of Medicine and Molecular Science
Zip code
Address 3-39-15 Showa, Maebashi, Gunma 371-8511
TEL 027-220-8127
Homepage URL
Email satoken@gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group (GLSG)
Institute
Department

Funding Source
Organization Gunma Liver Study Group (GLSG)
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
Email

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
2012 Year 04 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
2005 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2005 Year 08 Month 01 Day
Last follow-up date
2012 Year 08 Month 01 Day
Date of closure to data entry
2012 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 02 Month 01 Day
Date analysis concluded
2013 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 04 Month 05 Day
Last modified on
2015 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000487

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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