UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The significance of oral L-carnitine administration in liver cirrhotic patients -a comparative study of treatment efficacy and safety between L-carnitine and lactulose in patients with minimal hepatic encephalopathy-
Title of the study (Brief title)	The significance of oral L-carnitine administration in liver cirrhotic patients
Region	Japan

Condition
Condition	liver cirrhosis
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We perform the comparative study about the treatment efficacy and safety between each oral administration of L-carnitine and lactulose in patients with minimal hepatic encephalopathy(MHE).
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A comparative study about the ameliorated rate of MHE
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	The oral L-carnitine administration is performed.
Interventions/Control_2	The oral lactulose administration is performed.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Those who are more than 20 years old, those who have performance status 0 or 1, those who have decompensated cirrhosis with minimal hepatic encephalopathy, or those who have consent about this study are included in this study.
Key exclusion criteria	Those who have pregnancy, those who can not continue the treatment because of several diseases such as cancer therapy, or those who have difficulty for the enrollment of this study are excluded in this study.
Target sample size	60

Research contact person
Name of lead principal investigator	Yoshihiko Yano
Organization	Kobe University Graduate School of Medicine
Division name	Center for Infectious Diseases
Address	7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL	078-382-6305
Email	yanoyo@med.kobe-u.ac.jp

Public contact
Name of contact person	Hiroki Hayashi
Organization	Kobe University Hospital
Division name	Division of Gastroenterology
Address	7-5-2, Kusunoki-cho, Chuo-Ku, Kobe
TEL	078-382-6305
Homepage URL
Email	hhayashi@med.kobe-u.ac.jp

Sponsor
Institute	Kobe University Hospital Division of Gastroenterology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Kobe University Hospital Division of Gastroenterology
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 05 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 03 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2016 Year 04 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000023736