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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name