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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032394
Receipt No. 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 2018/04/26

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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
Middle name
Last name Masahiro Fukuda
Organization Fukuda Clinic
Division name Director
Zip code
Address Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka
TEL 06-6398-0203
Email fukuda@drmog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name Representative Director
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 28 Day
Last follow-up date
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
2018 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036940

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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