UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041614 |
|---|---|
| Receipt number | 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 | 2021/09/01 16:13:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
akiko-goto@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 15 | Day |
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
| 2021 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
