UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061696 |
|---|---|
| Receipt number | R000070594 |
| Scientific Title | A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms |
| Date of disclosure of the study information | 2026/05/26 |
| Last modified on | 2026/05/26 16:14:52 |
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Basic information
Public title
A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms
Acronym
A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms
Scientific Title
A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms
Scientific Title:Acronym
A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of test food on premenstrual symptoms over three consecutive menstrual cycles of intake
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Menstrual distress questionnaire (MDQ) Total Score and subscale score
Key secondary outcomes
Premenstrual Tension Syndrome Visual Analogue Scale (PMTS-VAS)
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Continuous intake of the test food (1 time a day) over three consecutive menstrual cycles
Interventions/Control_2
Continuous intake of the placebo food (1 time a day) over three consecutive 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
| 40 | years-old | > |
Gender
Female
Key inclusion criteria
(1) Healthy female participants who are aged 20 years or older and less than 40 years at the time of obtaining informed consent
(2) Participants in whom self-recognized premenstrual symptoms are confirmed during the preliminary screening and the pre-observation period
(3) Participants who report having a stable menstrual cycle length of 25 to 38 days
(4) Participants who report having a stable menstrual period duration of 3 to 7 days
(5) Participants who fully understand the purpose and details of the study and provide written informed consent to participate
Key exclusion criteria
(1) Participants who plan to become pregnant or breastfeed during the study period, and those who are pregnant or breastfeeding at the time of the preliminary screening
(2) Participants who wish to become pregnant during the study period
(3) Participants who are taking female hormone medications
(4) Participants who regularly use analgesics for menstrual pain
(5) Participants who have been diagnosed with gynecological disorders such as premenstrual dysphoric disorder (PMDD), premenstrual syndrome (PMS), breast cancer, cervical cancer, endometrial cancer, or ovarian cancer
(6) Participants who have serious diseases of the brain, liver, kidneys, heart, lungs, gastrointestinal system, hematologic system, endocrine system, or metabolic system
(7) Participants with a history of severe diseases that required medical treatment with pharmacotherapy
(8) Participants with chronic medical conditions that are under treatment
(9) Participants with a past or current history of mood disorders
(10) Participants with a Patient Health Questionnaire-9 (PHQ-9) score of 10 or higher
(11) Participants who are taking antidepressants or anxiolytics
(12) Participants who regularly use medications that may affect the study, including herbal medicines and contraceptives
(13) Participants who cannot discontinue the intake of foods rich in lactic acid bacteria or bifidobacteria (such as yogurt or lactic acid bacteria beverages) during the study period
(14) Participants who regularly use health foods or supplements that may affect the study (excluding those who can discontinue their use during the study period)
(15) Participants with allergies to dairy products or soy
(16) Participants with a BMI of 30 kg/m2 or above at the preliminary screening
(17) Participants who are judged unsuitable for the study by the investigator due to markedly abnormal anthropometric, physical, or clinical laboratory findings at the preliminary screening
The following items were entered in the 'Other ' section
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Gomi |
Organization
Yakult Honsha Co., Ltd.
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8960
atsushi-gomi@yakult.co.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Shimada |
Organization
EP Mediate Co., Ltd.
Division name
Development Department Trial Planning Section
Zip code
162-0814
Address
Acropolis TOKYO, 6-29 Shin-ogawamachi, Shinjuku-ku, Tokyo
TEL
090-5219-2774
Homepage URL
shimada.hiroyasu767@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha Co., Ltd.
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
Medical Station Clinic Research Ethics Committee
Address
3-12-8, Takaban, Meguro-ku, Tokyo
Tel
03-6452-2712
epmd_fd-erb@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
メディカルステーションクリニック (Medical station clinic) (東京都)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 26 | 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
| 2026 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Additional exclusion criteria are described below.
(18) Participants who have participated in other clinical studies within one month prior to obtaining informed consent, or who wish to participate in such studies during the study period
(19) Participants who smoke 21 or more cigarettes per day
(20) Participants who consume 20 g or more of pure alcohol per day on at least four days per week
(21) Participants with markedly irregular eating habits, such as frequently skipping two or more meals per day
(22) Participants with irregular lifestyles, such as those engaged in shift work or night work
(23) Participants who are judged unsuitable for the study based on the results of a lifestyle questionnaire
(24) Participants who are judged by the investigator to be unsuitable for the study for other reasons
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070594
