UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036778 |
|---|---|
| Receipt number | 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 09:38:01 |
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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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041904
