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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000036778
Receipt No. R000041904
Scientific Title Safety confirmation test by intake of food containing plant extract
Date of disclosure of the study information 2020/05/16
Last modified on 2019/06/17

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Basic information
Public title Safety confirmation test by intake of food containing plant extract
Acronym Safety confirmation test by intake of food containing plant extract
Scientific Title Safety confirmation test by intake of food containing plant extract
Scientific Title:Acronym Safety confirmation test by intake of food containing 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-containing food is overdose for 5 times amount to healthy adults of 20 to 80 years old for 4 weeks, and safety is evaluated after 2 weeks of follow-up.
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 5 times amount overdose of plant extract-containing food for 4 weeks
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
80 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 People with a history of liver, kidney, digestive system, heart disease, respiration, endocrine, metabolism, nerve, consciousness disorder, diabetes, seizures, and other diseases that may affect the results of this test, or Person who has a history of surgery. Patients who have been hospitalized for treatment due to stroke, subarachnoid hemorrhage, cerebral infarction, cerebral hemorrhage, brain contusion, head injury. Those who show abnormal liver and kidney function test values. Person who has disease under treatment now. Person with food and drug allergy. Person with anemia symptom. Those who have experienced ill mood or worsened physical condition by blood collection in the past. 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. Those who do intense sports and those who are on a diet. Person who has excessive smoking habit. Those who have an irregular diet. Persons who regularly use health food (including antioxidants, supplements with blood flow improvement effect) for the purpose of improving brain function or forgetfulness. Those who are taking medicines (anti-psychotic, anxiety, depressants, Parkinson's disease, epilepsy, blood clotting drugs, etc.) that may affect this study. Persons who can not quit the intake of health food (including food for specified health and functional indication food) or designated quasi-drugs during the test period. Those who are taking medication (including OTC and prescription drugs) continuously. Those who have consumed too much alcohol or who can not drink alcohol from the day before the test until the day. persons who are pregnant or who are planning pregnancy or breastfeeding during the study period. Those who are participating in or planning to participate in other clinical trials at the beginning of this trial, within 4 weeks after the end of the trial. 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
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
2020 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
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 17 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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