Treatment efficacy of BCAA on cognitive function and driving skill in patients with MHE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003581

Enrollment

Registered

2019-03-04

Start date

2019-03-29

Completion date

Unknown

Last updated

2019-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : BCAA treatments will cross over without placebo and will be given for 12 weeks each. The BCAA sanctions will be provided in-kind at Samil Pharma free of charge to each hospital. As a BCAA agent

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: .1) Persons 20 years of age or older and 65 years of age or younger 2) cirrhosis : Liver cirrhosis has been diagnosed by liver biopsy or one of the following 5 cases; (1) Image examination: The liver cirrhosis, including the nodular liver surface, morphologic changes in the liver (nodularity of the liver surface, atrophy of the right and left lobes, enlargement of the left and right lobes, enlargement of the portal vein, (2) upper gastrointestinal endoscopy (presence or absence of varices), (3) peripheral blood red blood cell count test (platelet reduction (=100,000 / mm3) Albumin reduction (=3.5 g / dL)), (5) prothrombin time extension (INR =1.3) 3) Those who have written consent before the commencement of research and are able to comply with the requirements of the research.

Exclusion criteria

Exclusion criteria: ,One or more of the following exclusion criteria: 1) A person who has been treated or is taking medication due to a neurological or psychiatric disorder that may affect the study as determined by the tester. 2) Those who are being treated for uncontrolled liver cancer and other malignancies 3) Those with viable hepatocellular carcinoma 4) Any infected or gastrointestinal bleeding within 6 weeks. 5) Those who had a history of mild hepatic encephalopathy within 3 months 6) Those with a history of BCAA, rifaximin, lactulose prescription within the last month. 7) Continued uncontrolled drinking patients 8) A person who is deemed impossible to study due to audiovisual disorder

Design outcomes

Primary

Measure	Time frame
BCAA administration improves cognitive function in patients with mnimal hepatic encephalopathy	—

Secondary

Measure	Time frame
Make sure that patients with minimal hepatic encephalopathy have a reduced driving ability and check if there is a change in driving ability after taking BCAA. In addition, it will be also checked whether it causes a lot of driving accidents at the same time.;Assessment of cognitive function and quality of life in patients with minimal hepatic encephalopathy, and whether they improve cognitive function and quality of life before and after BCAA administration.;Changes in intestinal bacterial flora and serum cytokines before and after administration of BCAA in patients with minimal hepatic encephalopathy.;Identify differences in muscle strength changes in patients with minimal hepatic encephalopathy.	—

Measure

Time frame

Make sure that patients with minimal hepatic encephalopathy have a reduced driving ability and check if there is a change in driving ability after taking BCAA. In addition, it will be also checked whether it causes a lot of driving accidents at the same time.;Assessment of cognitive function and quality of life in patients with minimal hepatic encephalopathy, and whether they improve cognitive function and quality of life before and after BCAA administration.;Changes in intestinal bacterial flora and serum cytokines before and after administration of BCAA in patients with minimal hepatic encephalopathy.;Identify differences in muscle strength changes in patients with minimal hepatic encephalopathy.

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Countries

Korea, Republic of

Contacts

Public ContactYoung Kul Jung

Korea University Ansan Hospital

93cool@hanmail.net+82-31-412-5114

Outcome results