UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy test of plant extracts for physical effect.
Acronym	Efficacy test of plant extracts for physical effect.
Scientific Title	A Study on the efficacy of plant extracts for physical effect.
Scientific Title:Acronym	Efficacy test of plant extracts for physical effect.
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To confirm the effect for physiological responses by physical therapy for healthy male
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the skin blood flow after the treatment with plant extracts.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Control sample application > wash out (24 h) > test sample A application > wash out (24 h) > test sample B application > wash out (24 h) > test sample C application
Interventions/Control_2	Test sample A application > wash out (24 h) > test sample B application > wash out (24 h) > test sample C application > wash out (24 h) > control sample application
Interventions/Control_3	Test sample B application > wash out (24 h) > test sample C application > wash out (24 h) > control sample application > wash out (1 da24 h y) > test sample A application
Interventions/Control_4	Test sample C application > wash out (24 h) > control sample application > wash out (24 h) > test sample A application > wash out (24 h) > test sample B application
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	59 years-old >=
Gender	Male
Key inclusion criteria	Healthy males
Key exclusion criteria	-Smokers -Subjects with hypertension, heart disease, diabetes mellitus and Raynaud's disease -Subjects with atopic dermatitis, eczema and pollen allergy
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Toyoshima
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	03-5630-7281
Email	toyoshima.yasuo@kao.com

Public contact
Name of contact person	1st name Yuichi Middle name Last name Tanabe
Organization	Kao Corporation
Division name	Personal Health Care Products Research
Zip code	131-8501
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
TEL	03-5630-9971
Homepage URL
Email	tanabe.yuichi@kao.com

Sponsor
Institute	Kao Corporation
Institute
Department

Funding Source
Organization	Kao Corporation
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	Human Research Ethics Committee, Kao Corporation
Address	2-1-3, Bunka, Sumida-ku, Tokyo 131-8501, Japan
Tel	+81-3-5630-7263
Email	morisaki.naoko@kao.com

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	花王株式会社（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 23 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	2019 Year 09 Month 27 Day
Date of IRB	2019 Year 09 Month 27 Day
Anticipated trial start date	2019 Year 10 Month 25 Day
Last follow-up date	2019 Year 11 Month 29 Day
Date of closure to data entry	2019 Year 12 Month 25 Day
Date trial data considered complete	2019 Year 12 Month 25 Day
Date analysis concluded	2020 Year 01 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 10 Month 17 Day
Last modified on	2020 Year 04 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043675