Healthy Japanese subjects
Conditions
Interventions
Duration: 8 weeks Test material: Active capsule Dose: One capsule per day Administration: Take a capsule with water or warm water after breakfast * If you forget to take the capsule, take it as
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Healthy Japanese female with experiencing unidentified complaints before and during menstruation 2. Subjects who are judged as eligible to participate in the study by the physician 3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose total scores in the MDQ are relatively high at screening (before consumption)
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who are diagnosed with premenstrual syndrome (PMS) or premenstrual dysphoric disorder (PMDD) 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Subjects who are currently taking medications (including herbal medicines and the pill) and supplements 6. Subjects who experience menopause 7. Subjects who are allergic to medicines and/or the test food related products 8. Subjects who are pregnant, lactation, or planning to become pregnant 9. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 10. Subjects who are judged as ineligible to participate in the study by the physician 11. Subjects who receive counseling or psychological therapy 12. Subjects who receive hormonal therapy 13. Subjects who suffer from mental disorders or have a medical history of mental disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Japanese version of the menstruation distress questionnaire (MDQ) * Assess the QOL before, during, and after menstruation * Compare the measured values between screening (before consumption) and 4 and 8 weeks after consumption | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SF-36 (Medical Outcomes Study Short-Form 36-Item Health Survey) 2. Questionnaire about symptoms during menstruation (Visual Analogue Scale) 3. Bust measurements (top and under) 4. Measure the height from the ground to top of the bust 5. Hip measurement 6. Waist measurement 7. Serum progesterone level 8. Serum estradiol level *1-8 Compare the measured values between screening (before consumption) and 4 and 8 weeks after consumption | — |
Countries
Japan
Contacts
Public ContactNaoko SUZUKI
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed