UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036672
Receipt number R000041788
Scientific Title Safety confirmation test by intake of plant extract
Date of disclosure of the study information 2021/05/16
Last modified on 2019/05/16 16:01:33

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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

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

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 or person

Institute

Oneness support CO., LTD

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041788


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name