UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031305
Receipt number R000035621
Scientific Title Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract
Date of disclosure of the study information 2018/02/15
Last modified on 2018/07/06 12:05:15

* 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

Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract

Acronym

Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract

Scientific Title

Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract

Scientific Title:Acronym

Overdose safety test by ingesting food with Kuromoji (Lindera umbellata) extract

Region

Japan


Condition

Condition

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study, the food with Kuromoji (Lindera umbellata) extract, is to verify the safety of when overdose.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Number of occurrences of side effects, expression rate (number of side effect examples / number of subjects to be analyzed for safety)

Key secondary outcomes

Number of occurrences of adverse events, incidence (number of adverse event developments / number of subjects to be analyzed for safety)


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

Oral ingestion of the test product (4 weeks)

Interventions/Control_2

Oral ingestion of the control product (4 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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

[1]Japanese males and females aged 20-65 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can come to the designated examination date and receive the examination
[5]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[3] Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[5]Individuals with history of gastrointestinal disorders except for appendicitis
[6]Individuals with skin disease, such as atopic dermatitis
[7]Individuals who have an inflammation or a scar on a measuring area
[8]Individuals who will get sunburned during the test period
[9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[10]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past
[11]Individuals with serious anemia
[12]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs
[13]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[14]Individuals whose number of smokers exceeds 20 on average per day
[15]Individuals whose life style will change during the test period (ex. travel for a long time)
[16]Individuals who are pregnant or are posslibly, or are lactating
[17]Individuals who participated in other clinical studies in the past three months
[18]Individual with potential conflict of interest
[19]Individuals judged inappropriate for the study by the principal

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshikazu Yonei

Organization

Faculty of Life and Medical Sciences,Doshisha University

Division name

Anti-Aging Medical Research Center

Zip code


Address

1-3 Tatara Miyakodani,Kyotanabe City,Kyoto

TEL

0774-65-6394

Email

yyonei@mail.doshisha.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuya Honda

Organization

DRC Co.,Ltd.

Division name

Product Testing & Studies Division

Zip code


Address

Tabuchi Bldg.No.9 3F,2-10-31,Higashi-Temma,Kita-ku,Osaka

TEL

06-6882-1130

Homepage URL


Email

honda@drc-web.co.jp


Sponsor or person

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

Yomeishu Seizo Co.,Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program


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

医療法人桜緑会日本橋さくらクリニック(東京都)


Other administrative information

Date of disclosure of the study information

2018 Year 02 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

2018 Year 01 Month 31 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 15 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 14 Day

Last modified on

2018 Year 07 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035621


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name