Healthy Japanese subjects
Conditions
Interventions
Duration: Approximately four weeks (one menstrual cycle) Take two active tablets with water per day during one menstrual cycle *If you forget to take the test food, take it as soon as you remember
Sponsors
ORTHOMEDICO Inc.
Medical Corporation Seishinkai, Takara Clinic Nerima Medical Association, Minami-machi Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Japanese 2. Women 3. Subjects aged between 20 and 40 4. Healthy subjects 5. Subjects whose menstrual cycle is between 25 and 38 days 6. Subjects whose lasting period of the menstruation is between three and seven days 7. Subjects whose total score of MDQ is relatively high
Exclusion criteria
Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who are undergoing medical treatment or have a medical history of gynopathy {such as premenstrual syndrome (PMS), premenstrual dysphoric Disorder (PMDD), secondary amenorrhea, dysmenorrhea, endometriosis, hysteromyoma, breast cancer, cervical cancer, endometrial carcinoma, and ovarian cancer} 5. Subjects without menstrual pain or symptoms associated with menstruation at all 6. Subjects who have severe menstrual pain that cannot be controlled with analgesics 7. Subjects who are undergoing medical treatment or have a medical history of psychiatric disorder 8. Subjects who receive hormonal therapy 9. Subjects who are currently taking low dose pill 10. Postmenopausal subjects 11. Subjects who use or take "Foods for Specified Health Uses," or "Foods with Functional Claims" in daily 12. Subjects who are currently taking medications (including herbal medicines) and supplements 13. Subjects who are allergic to medicines and/or the test food related products 14. Subjects who are pregnant, lactating, or planning to become pregnant during this trial 15. Subjects who suffer from COVID-19 16. Subjects who have been enrolled in other clinical trials within the last 28 days before the agreement to participate in this trial or plan to participate another trial during this trial 17. Subjects who are judged as ineligible to participate in this study by the physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The Menstrual Distress Questionnaire (MDQ) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The Profile of Mood States 2nd Edition (POMS2) Japanese version, the autonomic nervous system test, the OSA sleep inventory MA version (OSA-MA), the Uchida-Kraepelin psychodiagnostic test, the cognitive function test, anthropometric measurements, saliva test, skin test, an original questionnaire, and female hormone | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed