UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055141 |
|---|---|
| Receipt number | R000062995 |
| Scientific Title | A study to verify the effectiveness of test food intake in women on menstrual symptoms such as menstrual pain and PMS |
| Date of disclosure of the study information | 2024/08/02 |
| Last modified on | 2025/09/03 11:47:50 |
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Basic information
Public title
A study to verify the effectiveness of test food intake in women on menstrual symptoms such as menstrual pain and PMS
Acronym
A study to verify the effectiveness of test food intake in women on menstrual symptoms such as menstrual pain and PMS
Scientific Title
A study to verify the effectiveness of test food intake in women on menstrual symptoms such as menstrual pain and PMS
Scientific Title:Acronym
A study to verify the effectiveness of test food intake in women on menstrual symptoms such as menstrual pain and PMS
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy and safety of the test food on menstrual pain and menstrual symptoms caused by premenstrual syndrome (PMS) when the test food is ingested continuously for the duration of approximately two menstrual cycles will be compared with a placebo.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in menstrual pain VAS from before to after intake
Key secondary outcomes
Changes in menstrual symptoms Japanese version (MDQ), PMTS-VAS, bowel movement frequency, menstrual blood volume score, and wearable data from before to after intake
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion one bottle (200ml/bottle) of test food once a day for approximately two menstrual cycles.
Interventions/Control_2
Ingestion one bottle (200ml/bottle) of placebo once a day for approximately two menstrual cycles.
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
| 20 | years-old | <= |
Age-upper limit
| 45 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy females from 20 to 44 years of age
(2) Subjects with a stable menstrual cycle between 25 and 32 days
(3) Subjects who suffer from menstrual pain within 5 days of the start of menstruation
(4) Subjects whose usual menstrual cycle lasts 3-7 days based on their responses to a lifestyle questionnaire
(5) Priority will be given to subjects who, based on their responses to the lifestyle questionnaire, usually consume little similar food, and subjects who have a high total score on the menstrual VAS during menstruation and the MDQ score before menstruation at the time of the pre-test.
(6) Subjects who fully understand the purpose and content of this study and voluntarily agree to participate in the study
Key exclusion criteria
(1) Subjects who regularly consume beverages similar to the test food
(2) Subjects undergoing treatment for sex hormones, gynecological diseases, or taking birth control pills or related medications
(3) Subjects who have had abnormalities in clinical test values or cardiopulmonary function and are deemed to be unsuitable for participation in the study
(4) Subjects who are at risk of developing allergies related to the study
(5) Subjects with a disease requiring regular medication, subjects with a disease currently being treated (excluding dry eye and caries treatment), subjects with a history of a serious disease that required medication
(6) Subjects with a BMI of 30 kg/m^2 or more or less than 16 kg/m^2
(7) Subjects whose pre-examination anthropometric, physical and clinical test values are significantly outside the reference range
(8) Subjects who are participating in the other study at the start of this study
(9) Subjects who plan to or wish to receive cervical cancer (HPV) vaccination during the study period
(10) Subjects who plan to become pregnant or breastfeed during the study period
(11) Subjects who were deemed unsuitable as subjects based on their responses to the lifestyle questionnaire
(12) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Sho |
| Middle name | |
| Last name | Ishii |
Organization
Mizkan Holdings Co.,Ltd
Division name
Central Research Institute
Zip code
475-8585
Address
2-6 Nakamura-cho, Handa City, Aichi, Japan
TEL
0569-24-5139
s-ishii@mizkan.co.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Goto |
Organization
EP Mediate Co., Ltd.
Division name
R&D Support Center Foods Department Trial Planning Section
Zip code
162-0821
Address
Kagurazaka AK Bldg., 1-8 Tsukudocho, Shinjuku-ku, Tokyo
TEL
03-5657-9130
Homepage URL
goto.chiharu069@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co.,Ltd
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
nakagawa.akiko297@eps.co.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 同仁記念会 明和病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 02 | 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
| 2024 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 02 | Day |
Last modified on
| 2025 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062995
