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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 90 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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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. |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |