Tokyo, May 27 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061696) titled 'A clinical trial to evaluate the efficacy of test food in alleviating premenstrual symptoms' on May 26.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - EP Mediate Co., Ltd.
Condition:
Condition - Healthy adult
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the efficacy of test food on premenstrual symptoms over three consecutive menstrual cycles of intake
Basic objectives2 - Efficacy
Intervention:
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
Eligibility:
Age-lower limit - 20
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 Size - 140
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070594
Disclaimer: Curated by HT Syndication.
