UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018278 |
|---|---|
| Receipt number | R000021157 |
| Scientific Title | The investigation for the improvement of muscle mass and muscle strength using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with liver encephalopathy |
| Date of disclosure of the study information | 2015/07/12 |
| Last modified on | 2022/02/22 22:07:41 |
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Basic information
Public title
The investigation for the improvement of muscle mass and muscle strength using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with liver encephalopathy
Acronym
The investigation of muscle mass and muscle strength using a branched-chain amino acid in patients with decompensated liver cirrhosis
Scientific Title
The investigation for the improvement of muscle mass and muscle strength using a branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with liver encephalopathy
Scientific Title:Acronym
The investigation of muscle mass and muscle strength using a branched-chain amino acid in patients with decompensated liver cirrhosis
Region
| Japan |
Condition
Condition
decompensated liver cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement of muscle mass and muscle strength using a branched-chain amino acid (BCAA)-enriched nutrient (Aminoleban EN) in patients with liver cirrhosis associated with liver encephalopathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of muscle mass and muscle strength after administration of the agent
Key secondary outcomes
1)Change of blood cell count(WBC, RBC, lymphocyte, Plt)
2)Rate of side effect
3)compliance
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A branched-chain amino acid
(BCAA)-enriched nutrient (Aminoleban EN) twice daily for 6 months.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Cirrhotic patients with less than 3.5 g/dl of serum albumin level.
2.Cirrhotic patients with liver encephalopathy
3.Patients who will be able to obtain written informed consent.
4. Age is more 20 years old and less or equal 80 years old, male and female
Key exclusion criteria
1.Patients treated with albumin preparation.
2.Cirrhotic patients with less than 2.5 g/dl of serum albumin level.
3. Cirrhotic patients with more than 3.0 g/dl of serum bilirubin level.
4. Cirrhotic patients with more than third degree liver encephalopathy
5.Patients with history of hypersensitive against drugs.
6.Patients judged to be inappropriate for the study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 o,kamakura, kanagawa, japan
TEL
0467-46-1717
kiruha555@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | uojima haruki |
Organization
shonan kamakura general hospital
Division name
department of gastroenterology
Zip code
Address
1370-1 o,kamakura, kanagawa, japan
TEL
0467-46-1717
Homepage URL
kiruha555@yahoo.co.jp
Sponsor or person
Institute
shonan kamakura general hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
湘南鎌倉総合病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | 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
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
| 2015 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 12 | Day |
Last modified on
| 2022 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021157
