UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014100 |
|---|---|
| Receipt number | 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 19:06:30 |
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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
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
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
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
kuraion2@gmail.com
Public contact
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
kuraion2@gmail.com
Sponsor or person
Institute
Osaka City Juso Hospitcal
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016411
