UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007804 |
|---|---|
| Receipt number | 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 20:31:13 |
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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
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
Sponsor or person
Institute
Iwate Medical University, Department of Internal Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009193
