UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038871 |
|---|---|
| Receipt number | R000044299 |
| Scientific Title | Efficacy trial of 4 weeks ingestion of the development code MSHF001 food |
| Date of disclosure of the study information | 2019/12/13 |
| Last modified on | 2021/04/14 14:27:14 |
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Basic information
Public title
Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Acronym
Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Scientific Title
Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Scientific Title:Acronym
Efficacy trial of 4 weeks ingestion of the development code MSHF001 food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of MSHF001 (development code) food ingestion effects on general malaise in healthy females.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of 4 weeks ingestion of the development code MSHF001 food effects of on general malaise and so on.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
5
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In healthy females aged 40 to 59 years with subjective symptoms of hot flash, daily ingestion of two MSHF001(development code) food tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_2
In healthy females aged 40 to 59 years with subjective symptoms of hot flash, daily ingestion of two placebo food tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_3
In healthy females aged 40 to 59 years without subjective symptoms of hot flash, daily ingestion of two MSHF001 (development code) food Tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_4
In healthy females aged 40 to 59 years without subjective symptoms of hot flash, daily ingestion of two placebo food Tablets twice a day, after breakfast meals and at bed time for 4 weeks.
Interventions/Control_5
In healthy females aged 20 to 35 years, no intervention. Performing only one measurement.
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
Female
Key inclusion criteria
-Healthy females
1.Subjects at climacteric period who have the symptoms of hot flushes.
2.Subjects at climacteric period who have the symptoms of hot flushes.
3.Subjects between ages 20 and 35 who have stable menstrual cycle.
Key exclusion criteria
-Subjects with systemic illness.
-Subjects who are diagnosed as menopausal disorders.
-Subjects who are under Hormone Replacement Therapy, HRT, and/or medication which would affect blood hormone levels.
-Subjects who are outpatients or were treated by doctor within a month.
-Subjects who regularly take medicine.
-Subjects who regularly take medicines that affect menopausal symptoms.
-Subjects who are pregnant or lactating, or planned to become pregnant in the near future.
-Subjects with smoking habit.
-Subjects with drinking habit in 5 or more days a week.
-Subjects who have possibilities for emerging allergy to foods, metals, and drugs.
-Subjects with illnesses or diseases on their face, especially such as atopic dermatitis, or psoriasis, or severe acne.
-Subjects who habitually having specific polyphenol-rich health food and drink.
-Subjects with high anxiety questionnaire values.
-Subjects with high Kupperman Kohnenki Shohgai Index.
-Subjects who easily have skin rashes.
-Subjects with potential conflict of interest.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Yamamoto |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7538
yamamoto.naoki@kao.com
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Ohtsuka |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
321-3497
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7538
Homepage URL
ohtsuka.mayumi@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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（栃木県）
株式会社 リサーチ・アンド・ディベロプメント（東京）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 13 | 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
100
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 | 12 | Month | 04 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 13 | Day |
Last modified on
| 2021 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044299
