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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041614
Receipt No. R000047410
Scientific Title Improvement effect of test food on menopausal symptoms -A randomized, double blinded, placebo controlled, parallel group comparison study-
Date of disclosure of the study information 2020/08/31
Last modified on 2020/08/24

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Basic information
Public title Improvement effect of test food on menopausal symptoms
-A randomized, double blinded, placebo controlled, parallel group comparison study-
Acronym Improvement effect on menopausal symptoms
Scientific Title Improvement effect of test food on menopausal symptoms
-A randomized, double blinded, placebo controlled, parallel group comparison study-
Scientific Title:Acronym Improvement effect on menopausal symptoms
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of each test food on menopausal symptoms
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Simplified Menopausal Index(SMI), Severity and frequency of hot flash
Key secondary outcomes POMS2-AS,AIS, unidentified complaints

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of test food 1 for 8 weeks
Interventions/Control_2 Ingestion of test food 2 for 8 weeks
Interventions/Control_3 Ingestion of placebo for 8 weeks
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
60 years-old >=
Gender Female
Key inclusion criteria 1. Age: from 40 to 60 years old
2. Gender: Female
3. Menstruation: perimenopause (irregular menstruation in the last year) or postmenopause (less than 3 years from last menstruation)
4. Simplified Menopausal Index (SMI): 26 points or more
5.Hot flash: Daily hot flashes
Key exclusion criteria 1. Subjects who have serious medical history
2. Subjects who have severe diabetes
3. Subjects who receive treatment and/or medicine, which affect to result of the study
4. Subjects who have mental illness
5. Subjects who have thyroid gland malfunction
6. Subjects who take medicine or health foods, supplement that may affect the results of this study
7. Subjects who have been taking hormone replacement therapy now or within 3 months from the start of the study
8. Subjects who are allergic to test food (soybean)
9. Subjects with irregular eating habits and sleep rhythms (eg, late-night workers)
10.Subjects who may develop seasonal allergies, such as hay fever, that may interfere with sleep and daily life during the test period
11. Subjects who intend to become pregnant or lactating.
12. Subjects who are planned to participate in other clinical study.
13. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kei
Middle name
Last name Yui
Organization FANCL Corporation
Division name Research Institute
Zip code 244-0806
Address 12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL 045-820-3532
Email ke-yui@fancl.co.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Goto
Organization Kenkoin Medical Corporation Foundation
Division name Kenkoin Clinic
Zip code 104-0061
Address 6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL 03-3573-1153
Homepage URL
Email akiko-goto@kenkoin.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address 6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel 03-3573-1153
Email isamu-yanase@kenkoin.jp

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 医療法人財団健康院 健康院クリニック
医療法人社団盟生会 東新宿クリニック

Other administrative information
Date of disclosure of the study information
2020 Year 08 Month 31 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2020 Year 08 Month 31 Day
Last follow-up date
2020 Year 12 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 31 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047410

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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