UMIN-CTR Clinical Trial

Basic information
Public title	Safety confirmation test by intake of plant extract
Acronym	Safety confirmation test by intake of plant extract
Scientific Title	Safety confirmation test by intake of plant extract
Scientific Title:Acronym	Safety confirmation test by intake of plant extract
Region	Japan

Condition
Condition	Healthy Japanese adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The plant extract is taken by healthy men and women, and safety is confirmed.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Physical hand and physical examination Hematology and blood biochemistry Urinalysis Journal
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take the plant extract-containing food for 4 weeks to confirm safety.
Interventions/Control_2
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	64 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Healthy men and women aged 20 to 79 years old (2) BMI less than 30 (3) A person who has received a sufficient explanation of the purpose and contents of the study, has the ability to consent, voluntarily participates in a well-understood manner, and consents to the examination
Key exclusion criteria	(1) Liver disease, kidney disease, digestive system disease, heart disease, respiratory disorder, endocrine disorder, metabolic disorder, neurological disorder, consciousness disorder, diabetes, seizures, and other diseases that may affect the results of this test Person who has a medical history or who has a history of surgery (2) Patients who have been hospitalized for treatment due to stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, brain contusion, head injury (3) Those who show abnormal liver function and renal function test values (4) Person who has disease under treatment now (5) Person with food and drug allergy (6) Person with anemia symptom (7) Those who have experienced ill mood or worsened physical condition by blood collection in the past (8) Those who donated more than 200 mL from the month before the start of the test to the start of the test, or those who have plans for it during the test period (9) Those who do intense sports and those who are on a diet (10) Person who has excessive smoking habit (11) Those who have an irregular diet (12) Those who can not quit the intake of health food (including food for specified health and functional indication food) and designated quasi-drugs during the test period (13) Those who are taking medication (including OTC and prescription drugs) continuously (14) Those who are taking alcohol excessively or who can not drink alcohol from the day before the test until the day (15) Persons who are pregnant or who are planning pregnancy or lactation during the study period (16) Those who are participating in or planning to participate in other clinical trials at the beginning of this trial, and within 4 weeks after the end of the trial (17) Others who are judged inappropriate by the investigator
Target sample size	22

Research contact person
Last name of lead principal investigator	1st name Yoshiaki Middle name Last name Shiojima
Organization	RYUSENDO CO., LTD.
Division name	President and CEO
Zip code	171-0021
Address	1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL	03-3985-8346
Email	y.shiojima@ryusendo.co.jp

Public contact
1st name of contact person	1st name Megumi Middle name Last name Takahashi
Organization	RYUSENDO CO., LTD.
Division name	Development Office
Zip code	171-0021
Address	1-5-3 Nishi-ikebukuro, Toshima-ku, Tokyo 171-0021, Japan
TEL	03-3985-8346
Homepage URL
Email	m.takahashi@ryusendo.co.jp

Sponsor
Institute	Oneness support CO., LTD
Institute
Department

Funding Source
Organization	RYUSENDO CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Medical corporation Kanonkai Miura clinic ethics review committee
Address	Higasitenma Bld.9kai, 1-7-17, Higashitemma, Osaka Shi Kita Ku, Osaka Fu, 530-0044, Japan
Tel	06-6135-5200
Email	mterashima@miura-cl.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

Other administrative information
Date of disclosure of the study information	2021 Year 05 Month 16 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	0
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	Terminated
Date of protocol fixation	2019 Year 04 Month 22 Day
Date of IRB	2019 Year 04 Month 26 Day
Anticipated trial start date	2019 Year 05 Month 17 Day
Last follow-up date	2019 Year 07 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 08 Day
Last modified on	2019 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041788