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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034056
Receipt No. R000038818
Scientific Title Efficacy trial of ingestion of the development code MSHFS001.
Date of disclosure of the study information 2018/09/13
Last modified on 2020/12/08

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Basic information
Public title Efficacy trial of ingestion of the development code MSHFS001.
Acronym Efficacy trial of ingestion of the development code MSHFS001.
Scientific Title Efficacy trial of ingestion of the development code MSHFS001.
Scientific Title:Acronym Efficacy trial of ingestion of the development code MSHFS001.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the development code MSHFS001 efficacy on menopausal symptoms 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 MSHFS001 on menopausal symptoms 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 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Daily ingestion of six MSHFS001 tablets before bedtime for 4 weeks.
Interventions/Control_2 Daily ingestion of six placebo tablets before bedtime 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 females
-Subjects whose Kupperman Kohnenki Shohgai Index (KKSI) are more than medium degree, or below medium degree on a case by case basis.
-Subjects who have the symptoms of hot flushes.
Key exclusion criteria -Subjects who have been suffered from disease.
-Subjects who regularly take medicine.
-Subjects who are undergoing medical treatment or were treated by doctor within a month.
-Subjects who are under hormone replacement therapy (HRT), and / or subjects who are in medication that affect blood hormone levels.
-Subjects who regularly take supplements related to menopausal symptoms.
-Subjects who regularly take functional food and/or supplements related to sleep.
-Subjects who are pregnant, lactating, or planned to become pregnant during the test period.
-Subjects with smoking habit.
-Subjects who cannot follow the restriction of eating habit.
-Subjects who have possibilities for emerging allergy to foods, metals, and drugs.
-Subjects who are shift workers.
-Subjects deemed inappropriate to participate in this study by the principle investigator.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Kataoka
Organization Kao Corporation
Division name Health Care Food Research
Zip code 131-8501
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL +81-3-5630-9877
Email kataoka.kiyoshi@kao.com

Public contact
Name of contact person
1st name Yuka
Middle name
Last name Enokuchi
Organization Kao Corporation
Division name Health Care Food Research
Zip code 131-8501
Address 2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL +81-3-5630-9877
Homepage URL
Email enokuchi.yuka@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 +81-3-5630-9220
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)
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 09 Month 13 Day

Related information
URL releasing protocol https://www.mdpi.com/2072-6643/12/12/3757
Publication of results Published

Result
URL related to results and publications https://www.mdpi.com/2072-6643/12/12/3757
Number of participants that the trial has enrolled 82
Results The results show that continuous intake of CGAs resulted in improvements in menopausal symptoms, especially hot flushes, in healthy women.
Results date posted
2020 Year 12 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics The inclusion criteria for the subjects were as follows: healthy
women 40 to 59 years of age, moderate or severe rating according to the modified Kupperman menopausal index (mKMI) severity grading (including a moderate or a lower score in some cases), and subjective
symptoms of hot flushes. The exclusion criteria were as follows: those affected by disease; taking regular
medication; receiving regular outpatient treatment at a medical facility or visited a hospital within one
month prior to the pre-examination; taking HRT; taking medication that may interfere with hormones;
regularly taking supplements that affect menopausal symptoms; regularly taking functional foods
and supplements that have been shown to be effective in improving sleep; pregnant, breastfeeding,
or willing to become pregnant during the study period; smokers; unable to follow the dietary restrictions
during the study period; known to have a past or current history of allergies; leading irregular lifestyles;
or deemed unfit for enrollment by the physician in charge or by the principal investigator due to other
causes.
Participant flow https://www.mdpi.com/2072-6643/12/12/3757
Adverse events None
Outcome measures https://www.mdpi.com/2072-6643/12/12/3757
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2018 Year 08 Month 23 Day
Date of IRB
2018 Year 08 Month 23 Day
Anticipated trial start date
2018 Year 09 Month 18 Day
Last follow-up date
2018 Year 12 Month 06 Day
Date of closure to data entry
2019 Year 04 Month 24 Day
Date trial data considered complete
2019 Year 04 Month 24 Day
Date analysis concluded
2019 Year 11 Month 26 Day

Other
Other related information

Management information
Registered date
2018 Year 09 Month 06 Day
Last modified on
2020 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038818

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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