UMIN-CTR Clinical Trial

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
Email	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
Email	kiruha555@yahoo.co.jp

Sponsor
Institute	shonan kamakura general hospital
Institute
Department

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
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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021157