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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007804
Receipt No. R000009193
Scientific Title The effect of nutritional therapy for subclinical hepatic encephalopathy in liver cirrhosis;preliminary multicenter study in Japan-
Date of disclosure of the study information 2012/04/21
Last modified on 2012/04/20

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Basic information
Public title The effect of nutritional therapy for subclinical hepatic encephalopathy in liver cirrhosis;preliminary multicenter study in Japan-
Acronym Nutritional therapy for subclinical hepatic encephalopathy
Scientific Title The effect of nutritional therapy for subclinical hepatic encephalopathy in liver cirrhosis;preliminary multicenter study in Japan-
Scientific Title:Acronym Nutritional therapy for subclinical hepatic encephalopathy
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of nutritional therapy for subclinical hepatic encephalopathy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The primary endopoint is to evaluate the ratio of improved SHE.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Diet group:
Energy 30-35 kcal/kg
Protein 1.0-1.2 g/kg
Interventions/Control_2 Aminoleban EN group:
The total calorie and protein is estimated as the same as diet group and it includes two sachets of Aminoleban EN.
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
70 years-old >
Gender Male and Female
Key inclusion criteria 1)Viral liver cirrhosis patients who are younger than seventy years old
2)More than two abnormal NP-tests out of four tests
3)Obtained informed consent
4)Post-operative HCC patients who are judged as adequate for this trial
5)Without obvious HE
Key exclusion criteria 1)History of HE
2)Take or will take the treatment for THIPS and esophagogastric varices in the examination period.
3)Impossible to perform NP-tests
4)Judged unsuitable by personal physician
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akinobu Kato
Organization Morioka municipal hospital
Division name Department of Gastroenterology
Zip code
Address Koyashiki,Motomiya-aza,Morioka-city, 15-1,020-0866
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Morioka municipal hospital
Division name Department of Gastroenterology
Zip code
Address Koyashiki,Motomiya-aza,Morioka-city, 15-1,020-0866
TEL
Homepage URL
Email

Sponsor
Institute Iwate Medical University, Department of Internal Medicine
Institute
Department

Funding Source
Organization Iwate Medical University, Department of Internal Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 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 08 Month 01 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2012 Year 04 Month 20 Day
Last modified on
2012 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009193

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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