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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023476
Receipt No. 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 2017/02/20

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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
Middle name
Last name YASUO THO
Organization Medical Corporation Association KUNWA-KAI
AIWA CLINIC
Division name Medical office
Zip code
Address 1-590-1 Kawayanagicho, Koshigaya-shi, Saitama
TEL 048-989-2000
Email kunwakai@aiwacl.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshika Komori
Organization KSO Corporation
Division name Sales department
Zip code
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

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
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
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
2017 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027016

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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