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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027214
Receipt No. R000031185
Scientific Title A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Date of disclosure of the study information 2017/06/16
Last modified on 2017/09/07

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Basic information
Public title A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Acronym A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Scientific Title A clinical trial about the safety of 5 times amount intake of Chrysanthemum Morifolium Flower extract
Scientific Title:Acronym 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
1st name
Middle name
Last name Hiroshi Shimoda
Organization ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name R & D Center
Zip code
Address 1 Numata Kitagata Kitagata-cho Ichinomiya-city Aichi-pref.
TEL 0586865141
Email kaihatsu@mri.biglobe.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuya Toda
Organization ORYZA OIL & FAT CHEMICAL CO., LTD.
Division name Food Development Dept. R & D Center
Zip code
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)

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
2017 Year 06 Month 16 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
2017 Year 05 Month 01 Day
Date of IRB
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

Other
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

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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