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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014100
Receipt No. R000016411
Scientific Title Frequency of sarcopenia and efficacy of levo carnitine(We change it to Levocarnitine from May 15, 2015) in patients with liver cirrhosis
Date of disclosure of the study information 2014/05/30
Last modified on 2015/05/28

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Basic information
Public title Frequency of sarcopenia and efficacy of levo carnitine(We change it to Levocarnitine from May 15, 2015) in patients with liver cirrhosis
Acronym Frequency of sarcopenia and efficacy of levo carnitine in patients with liver cirrhosis
Scientific Title Frequency of sarcopenia and efficacy of levo carnitine(We change it to Levocarnitine from May 15, 2015) in patients with liver cirrhosis
Scientific Title:Acronym Frequency of sarcopenia and efficacy of levo carnitine in patients with liver cirrhosis
Region
Japan

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

Objectives
Narrative objectives1 1. To evaluate the frequency of sarcopenia in the patients who diagnosed as liver cirrhosis.
2. (sarcopenia group) To evaluate the efficacy of excercise and levo carnitine chloride for the improvement of muscle mass and muscle strength
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes efficacy of levo carnitine chloride(We change it to Levocarnitine from May 15, 2015)
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 Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 levo carnitine chloride 1800 mg/day
lifestyle intervention(We change it to Lebocarnitine 1500mg/day from May 15, 2015)
Interventions/Control_2 lifestyle intervention
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who clinically diagnosed as liver cirrhosis
Key exclusion criteria patients with pacemaker
patients with metal in their body
Target sample size 100

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Osamu Kurai
Organization Osaka City Juso Hospitcal
Division name Department of Gastroenterology
Zip code
Address 2-12-27, nonakakita, yodogawa-ku, Osaka
TEL 06-6150-8000
Email kuraion2@gmail.com

Public contact
1st name of contact person
1st name
Middle name
Last name Osamu Kurai
Organization Osaka City Juso Hospitcal
Division name Department of Gastroenterology
Zip code
Address 2-12-27, nonakakita, yodogawa-ku, Osaka
TEL 06-6150-8000
Homepage URL
Email kuraion2@gmail.com

Sponsor
Institute Osaka City Juso Hospitcal
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 Osaka City Juso Hospitcal
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

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 30 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 Open public recruiting
Date of protocol fixation
2014 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
2018 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
2014 Year 05 Month 28 Day
Last modified on
2015 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016411


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