UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034957 |
|---|---|
| Receipt number | R000039860 |
| Scientific Title | Clinical trial on the efficacy and safety of Nobilex 90 to fatty liver |
| Date of disclosure of the study information | 2018/11/26 |
| Last modified on | 2023/07/10 15:12:21 |
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Basic information
Public title
Clinical trial on the efficacy and safety of Nobilex 90 to fatty liver
Acronym
Clinical trial of Nobilex 90 to fatty liver
Scientific Title
Clinical trial on the efficacy and safety of Nobilex 90 to fatty liver
Scientific Title:Acronym
Clinical trial of Nobilex 90 to fatty liver
Region
| Japan |
Condition
Condition
Fatty liver
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of the nobiletin mixture to fatty liver is examined in the group administered with Novilex 90 and the group administered placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Liver ultrasound examination: liver renal contrast, intrahepatic vessel obscurity, deep attenuation
Key secondary outcomes
Blood biochemical test (GOT, GPT, gamma-GTP, T-Bil, LDH, ALP, TP, ALB, BUN, CRE, Adiponectin)
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
The actual drug group to which Novilex 90 (nobiletin mixture 50 mg) is administered and the place group to which placebo is administered
Interventions/Control_2
8 weeks administration
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
Increase of liver and kidney contrast on ultrasonography
Key exclusion criteria
The liver is untreated
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southern Knights' Laboratory Co., Ltd.
Division name
Southern Knights' Laboratory
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa, 904-0113 Japan
TEL
090-4998-7459
sugaya@med.u-ryukyu.ac.jp
Public contact
Name of contact person
| 1st name | Kimio |
| Middle name | |
| Last name | Sugaya |
Organization
Southern Knights' Laboratory Co., Ltd.
Division name
Southern Knights' Laboratory
Zip code
904-0113
Address
1-1-823 Miyagi, Chatan, Okinawa, 904-0113 Japan
TEL
090-4998-7459
Homepage URL
sugaya@med.u-ryukyu.ac.jp
Sponsor or person
Institute
Southern Knights' Laboratory Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Okinawa TLO Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Okinawa Research Center Co.,Ltd.
IRB Contact (For public release)
Organization
Kawahara Urological Clinic
Address
73-3Nishimotida, Aira, Kagoshima, Japan
Tel
0995-64-5181
yamashita.hami@kawahara.or.jp
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
西﨑病院（沖縄県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 26 | 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
| 2018 | Year | 11 | Month | 13 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 02 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039860
