UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025685 |
|---|---|
| Receipt number | R000027922 |
| Scientific Title | Effects of Misatol GL , a heat-concentrated extract from Japanese green apricot, in patients with non-alcoholic fatty liver disease / non-alcoholic steatohepatitis -Multicenter trial- |
| Date of disclosure of the study information | 2017/01/15 |
| Last modified on | 2020/01/22 16:17:48 |
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Basic information
Public title
Effects of Misatol GL , a heat-concentrated extract from Japanese green apricot, in patients with non-alcoholic fatty liver disease / non-alcoholic steatohepatitis -Multicenter trial-
Acronym
Effects of Japanese apricot extract (Misatol GL) in patients with NAFLD /NASH
Scientific Title
Effects of Misatol GL , a heat-concentrated extract from Japanese green apricot, in patients with non-alcoholic fatty liver disease / non-alcoholic steatohepatitis -Multicenter trial-
Scientific Title:Acronym
Effects of Japanese apricot extract (Misatol GL) in patients with NAFLD /NASH
Region
| Japan |
Condition
Condition
NAFLD/NASH
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine the effects of Misatol GL on serum ALT in patients with NAFLD /NASH
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in serum ALT
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Misatol GL twice (6.5g x 2) per day for 8 weeks
Interventions/Control_2
Placebo twice (6.5g x 2) per day for 8 weeks
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients with hepatic steatosis is suspected by abdominal US, CT or MRI tests.
2. ALT higher than 60 IU/L
3. Patients who are able to provide written informed consent.
Key exclusion criteria
1. Patients who have serious liver disease (decompensated cirrhosis (Child-Pugh B<), liver cancer), whose ALT higher than 300 IU/L, or jaundice.
2. Other chronic liver disease (alcoholic liver disease, virus hepatitis, autoimmune hepatitis, metabolic liver disease)
3. Patients who have undergone bariatric surgery.
4. Pregnant woman, lactating woman, or a woman suspected of pregnancy.
5. Patients under insulin treatment.
6. Patients with severe cardiac disease.
7. Patients with severe kidney disease (CRE>2.0 mg/dL).
8. Patients who are unable to comply with administrative matters.
9. Patients who are allergic to the test foods.
10. Patients who have alcohol intake more than 30 g/day for male, and more than 20 g/day for female.
11. Patients who have participated in a clinical trials in the last 3 months.
12. Patients who are currently taking Misatol.
13. Patients who are judged by the investigator not to be appropriate for inclusion in the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mikio Zeniya |
Organization
Sanno Medical Center
Division name
Department of Internal Medicine
Zip code
Address
8-5-35, Akasaka, Minato-ku, Tokyo, 105-0003, Japan
TEL
03-3402-5581
zeniya@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Ueda |
Organization
Medical Edge Inc.
Division name
Sytem Development
Zip code
Address
2-12-8, Shinjuku, Shinjuku-ku, Tokyo, 160-0022, Japan
TEL
03-4400-7070
Homepage URL
system-info@medicaledge.jp
Sponsor or person
Institute
Sanno Medical Center
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Factory, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
1.Jntenndo University Hospital
2.The Jikei University Daisan Hospital
3.Tokyo Metropolitan Bokutoh Hospital
4.Kyoundo Hospital
5. Chiba University Hospital
6.Kitaibaraki City Hospital
7.Shibata Hepatology Clinic
8.Toshima Hospital
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
| 2017 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2016 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 08 | Month | 22 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 22 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 15 | Day |
Last modified on
| 2020 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027922
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