UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034056 |
|---|---|
| Receipt number | 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 10:22:53 |
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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
| Obstetrics 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
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
enokuchi.yuka@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
+81-3-5630-9220
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038818
