UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034957
Receipt No. 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 2019/05/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email sugaya@med.u-ryukyu.ac.jp

Sponsor
Institute Southern Knights' Laboratory Co., Ltd.
Institute
Department

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
Email 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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 13 Day
Date of IRB
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

Other
Other related information

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2019 Year 05 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039860

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.