UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012336 |
|---|---|
| Receipt number | R000014422 |
| Scientific Title | Study for the effect of Stronger Neo-Minophagen C (SNMC) for nonalcoholic fatty liver disease (NAFLD)-multicenter clinical trial- |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2015/03/30 17:22:39 |
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Basic information
Public title
Study for the effect of Stronger Neo-Minophagen C (SNMC) for nonalcoholic fatty liver disease (NAFLD)-multicenter clinical trial-
Acronym
Study for the effect of SNMC for NAFLD
Scientific Title
Study for the effect of Stronger Neo-Minophagen C (SNMC) for nonalcoholic fatty liver disease (NAFLD)-multicenter clinical trial-
Scientific Title:Acronym
Study for the effect of SNMC for NAFLD
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
To examine whether Stronger Neo-Minophagen C is effective for nonalcoholic fatty liver disease
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
ALT, gamma-GTP
Key secondary outcomes
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
Stronger Neo-Minophagen C
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Fatty liver is diagnosed by ultrasonography.
2. ALT is more than 30 IU/L or abnormal of gamma GTP.
3. Abailable to continue to recieve Stronger Neo-Minophagen C for 1 month.
4. Obtained written informed concent from patient.
Key exclusion criteria
1. HBV or HCV infection.
2. Alcohol drinking more than 20g-ethanol per day.
3. Malignancy
4. Hepatic encephalopathy
5. Active infection
6. Severe complication
7. Pregnant, child-bearing potential or breast-feeding woman.
8. Ineligible for study judged by Medical Docor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Ido |
Organization
Kagoshima University Hospital
Division name
Division of Gstroenterological Mdicine
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima, Japan
TEL
099-275-5326
ido-akio@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirofumi Uto |
Organization
Kagoshima University Hospital
Division name
Division of Gstroenterological Mdicine
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima, Kagoshima, Japan
TEL
099-275-5326
Homepage URL
hirouto@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Division of Gstroenterological Mdicine, Kagoshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kagshima University Graduate School of Medical and Dental Sciences
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
| 2013 | Year | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Terminated
Date of protocol fixation
| 2013 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 18 | Day |
Last modified on
| 2015 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014422
