UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Title of the study (Brief title)	A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Region	Japan

Condition
Condition	healthy subject
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the safety for oral intake of Chrysanthemum Morifolium Flower extract
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood test 4 weeks after intake atart
Key secondary outcomes	Blood pressure, pulse, urinalysis and questionnaire 4 weeks after intake start

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	500mg/day Chrysanthemum Morifolium Flower extract supplementation (4 weeks)
Interventions/Control_2	500mg/day placebo supplementation (4 weeks)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Healthy subjects, male and female, who are 20 years of age or over
Key exclusion criteria	1) Subjects in medication, or who have anamnesis with serious disease that require medication 2) Subjects with chronic disease of asthma 3) Subjects who are allergic to the test sample
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroshi Shimoda
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name	R & D Center
Address	1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL	0586865141
Email	kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person	Kazuya Toda
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name	Food Development Dept. R & D Center
Address	1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL	0586865141
Homepage URL
Email	kaihatsu@mri.biglobe.ne.jp

Sponsor
Institute	ORYZA OIL & FAT CHEMICAL CO., LTD.
Institute
Department

Funding Source
Organization	ORYZA OIL & FAT CHEMICAL CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 06 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 05 Month 01 Day
Anticipated trial start date	2017 Year 05 Month 16 Day
Last follow-up date	2017 Year 06 Month 13 Day
Date of closure to data entry	2017 Year 07 Month 13 Day
Date trial data considered complete	2017 Year 07 Month 16 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 05 Month 01 Day
Last modified on	2017 Year 09 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031185