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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025685
Receipt No. 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 2019/07/24

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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
Email 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
Email system-info@medicaledge.jp

Sponsor
Institute Sanno Medical Center
Institute
Department

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
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
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 No longer recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 01 Month 15 Day
Last modified on
2019 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027922

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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