Healthy subjects
Conditions
Interventions
Sponsors
Miura Clinic, Medical Corporation Kanonkai
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: (1) Women aged 20 to 49 years old. (2) Subjects with premenstrual syndrome (PMS) symptoms. (3) Subjects with a menstrual cycle of approximately 26 to 32 days, and cycle variability within plus or minus days. (4) Subjects who received sufficient explanation about the purpose and content of the test, had the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the test in writing
Exclusion criteria
Exclusion criteria: (1) Subjects with a history of diabetes, liver disease, renal disease, gastrointestinal disease, heart disease, respiratory disease, peripheral vascular disease, or other serious disease (2) Subjects who have undergone gastrointestinal surgery. (3) Subjects showing abnormal liver and kidney function test values. (4) Subjects with diseases currently being treated (5) Subjects with food and drug allergies (6) Subjects with symptoms of anemia. (7) Female subjects who wish to become pregnant while participating in this study, female subjects who are pregnant (including those who may be pregnant) or who are breastfeeding (8) Subjects taking hormone medication. (9) Subjects who play intense sports and subjects who are on a diet (10) Subjects with extremely irregular eating habits (11) Subjects who cannot stop taking health foods (including foods for specified health use and foods with functional claims) and quasi-drugs during the test period (12) Subjects who are continuously undergoing treatment with pharmaceuticals (including OTC and prescription medications). (13) Subjects who drink more than 40g of average daily pure alcohol (14) Subjects who smoke an average of 21 or more cigarettes a day (15) Subjects who are participating in or will participate in other clinical trials at the start of this study (16) Subjects who are otherwise deemed inappropriate for the study by the principal investigator or subinvestigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mood Disorder Questionnaire Premenstrual Symptoms Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| OSA sleep inventory MA version Profile of Mood States 2nd Edition Short Form Clinical tests (hematological tests, blood biochemistry tests 1, urinalysis) Height, weight, physical examination Blood hormone items (estrogen, progesterone) Metabolome analysis PMS memory Basal body temperature Ovulation day | — |
Countries
Japan
Contacts
Public ContactMakoto Terashima
Oneness Support Co., Ltd. Clinical Trial Division
Outcome results
None listed