UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023476 |
|---|---|
| Receipt number | R000027016 |
| Scientific Title | A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract -Open Study- |
| Date of disclosure of the study information | 2016/08/05 |
| Last modified on | 2021/02/17 16:24:01 |
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Basic information
Public title
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract
-Open Study-
Acronym
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract
Scientific Title
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract
-Open Study-
Scientific Title:Acronym
A Clinical Study for Evaluating the Safety of Excessive Consumption of Food containing Pueraria Flower Extract
Region
| Japan |
Condition
Condition
No (Subjects under 30 of BMI)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of excessive consumption of food containing pueraria flower extract
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biochemical examination, Hematological examination, urine analysis, vital signs
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
Food containing pueraria flower extract, 5-fold quantity of recommended daily intake
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females whose age are from 20 to 64, and BMI are under 30.
(2) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1) Subjects who are under medical treatment.
(2) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, liver disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder).
(3) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) during test periods.
(4) Subjects who can't stop drinking from 2 days before each measurement.
(5) Subjects who have declared allergic reaction to ingredients of test foods.
(6) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating.
(7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(8) Subjects who are shiftworker and/or midnight-shift worker.
(9) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(10) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | YASUO |
| Middle name | |
| Last name | THO |
Organization
Medical Corporation Association KUNWA-KAI
AIWA CLINIC
Division name
Medical office
Zip code
343-0827
Address
1-590-1 Kawayanagicho, Koshigaya-shi, Saitama
TEL
048-989-2000
kunwakai@aiwacl.or.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
AIWA CLINIC institutional review board
Address
1-590-1 Kawayanagicho,Koshigaya-shi, Saitama-ken 343-0827Japan
Tel
048-989-2000
kunwakai@aiwacl.or.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
| 2016 | Year | 08 | Month | 05 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 19 | 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
| 2016 | Year | 08 | Month | 04 | Day |
Last modified on
| 2021 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027016
