UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011118 |
|---|---|
| Receipt number | R000013029 |
| Scientific Title | The usefulness of glutathione for the treatment of NAFLD: a pilot study |
| Date of disclosure of the study information | 2013/07/10 |
| Last modified on | 2013/07/04 16:17:44 |
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Basic information
Public title
The usefulness of glutathione for the treatment of NAFLD: a pilot study
Acronym
NAFLD-GSH study
Scientific Title
The usefulness of glutathione for the treatment of NAFLD: a pilot study
Scientific Title:Acronym
NAFLD-GSH study
Region
| Japan |
Condition
Condition
Nonalcoholic fatty liver disease
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of usefulness for the treatment of NAFLD
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
ALT
Key secondary outcomes
steatosis
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
glutathione
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
NAFLD patients resistant to dietary and exercise therapies
Key exclusion criteria
decompensated cirrhosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YOSHIO SUMIDA |
Organization
KYOTO PREFECTURAL UNIVERSITY of MEDICINE
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kamigyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YOSHIO SUMIDA |
Organization
KYOTO PREFECTURAL UNIVERSITY of MEDICINE
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
sumida@koto.kpu-m.ac.jp
Sponsor or person
Institute
Japan Study Group of NAFLD (JSG-NAFLD)
Institute
Department
Personal name
Funding Source
Organization
Kohjin Life Science
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Birdsview
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
横浜市立大学
旭川医科大学
大阪市立大学
久留米大学
佐賀大学
広島大学
市立奈良病院
高知大学
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | 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
| 2013 | Year | 07 | Month | 04 | Day |
Last modified on
| 2013 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013029
