UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032394 |
|---|---|
| Receipt number | R000036940 |
| Scientific Title | Safety assessment study of continuous intake of plant extract containing food |
| Date of disclosure of the study information | 2019/05/20 |
| Last modified on | 2023/05/01 09:37:51 |
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Basic information
Public title
Safety assessment study of continuous intake of plant extract containing food
Acronym
Safety assessment study of plant extract containing food
Scientific Title
Safety assessment study of continuous intake of plant extract containing food
Scientific Title:Acronym
Safety assessment study of plant extract containing food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the safety of 7-day continuous intake of the tablet containing plant extract
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety evaluation index (blood test, urine test, physical examination, medical interview)
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of test food for 7 days
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
| 45 | years-old | <= |
Age-upper limit
| 64 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Healthy males whose age of 45 years or more and 64 years or less
2)Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntary participate in the study and being able to personally sign a written informed consent
Key exclusion criteria
1) Subjects receiving a medical treatment for serious renal, hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders or having a medical history of these disorders
2) Subjects who take anticholinergic drug, acetylcholinesterase inhibitor, or cholinergic agonist
3) Subjects who have the possibility of developing allergic symptoms by the test food
4) Subjects who are taking part in another clinical study when starting of the present study
5)Subjects having blood sample of over 200 ml within 1 month, or over 400 ml within 3 months prior to the start of the present study (e.g. donated blood)
6) Subjects deemed unsuitable by the investigator
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
Representative Director
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
sugino@soiken.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Sugino |
Organization
Soiken Inc.
Division name
Representative Director
Zip code
560-0082
Address
Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL
06-6871-8888
Homepage URL
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
Funding Source
Organization
API 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
IRB of Fukuda Clinic
Address
Shin-Osaka brick building 2F, 1-6- 1 Miyahara, Yodogawa, Osaka
Tel
06-6398-0203
fukudaclinicIRB@gmail.com
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
| 2019 | Year | 05 | Month | 20 | 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 | 03 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 26 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
