UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy trial of 4 weeks ingestion of the development code MSHF001
Acronym	Efficacy trial of 4 weeks ingestion of the development code MSHF001
Scientific Title	Efficacy trial of 4 weeks ingestion of the development code MSHF001
Scientific Title:Acronym	Efficacy trial of 4 weeks ingestion of the development code MSHF001
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the development code MSHF 001 efficacy on general malaise, and so on, in healthy females.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Efficacy of the 4 weeks ingestion of the development code MSHF001 on general malaise and so on.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Daily ingestion of two sugar-coated MSHF001 pills twice a day, after breakfast meals and at bed time for 4 weeks. After about 4 weeks washout period, daily ingestion of two sugar-coated placebo pills twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_2	Daily ingestion of two sugar-coated placebo pills twice a day, after breakfast meals and at bed time for 4 weeks. After about 4 weeks washout period, daily ingestion of two sugar-coated MSHF001 pills twice a day, after breakfast meals and at bed time for 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	40 years-old <=
Age-upper limit	59 years-old >=
Gender	Female
Key inclusion criteria	-Healthy female -Subjects whose Kupperman Kohnenki Shohgai Index, KKSI, is more than medium degree, or below medium on a case by case basis. -Subjects who have the symptoms of hot flushes.
Key exclusion criteria	-Subjects with systemic illness -Subjects who regularly take medicine. -Subjects who are outpatients or were treated by doctor within a month. -Subjects who are under Hormone Replacement Therapy, HRT, and/or medication which would affect blood hormone levels. -Subjects who are pregnant or lactating, or planned to become pregnant in the near future. -Subjects with smoking habit. -Subjects with drinking habit in 4 or more days a week. -Subjects who have possibilities for emerging allergy to foods, metals, and drugs. -Subjects who easily have skin rashes. -Subjects with potential conflict of interest. -Subjects who plan to participate in other clinical trials during this study. -Subjects who are judged to be inappropriate for this study by the investigator for other reason.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoki Yamamoto
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7468
Email	yamamoto.naoki@kao.com

Public contact
Name of contact person	1st name Middle name Last name Mayumi Ohtsuka
Organization	Kao Corporation
Division name	Biological Science Research
Zip code
Address	2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL	+81-285-68-7458
Homepage URL
Email	ohtsuka.mayumi@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
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	花王株式会社 栃木事業所（栃木県） 株式会社 リサーチ・アンド・ディベロプメント（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 06 Month 30 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	2018 Year 06 Month 22 Day
Date of IRB	2018 Year 06 Month 22 Day
Anticipated trial start date	2018 Year 07 Month 01 Day
Last follow-up date	2018 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 06 Month 29 Day
Last modified on	2019 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037845