Effects of consumption of the test food on unidentified complaints of menstruation in healthy Japanese wome
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000049157
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 44
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The Menstrual Distress Questionnaire (MDQ)
- Secondary Outcome Measures
Name Time Method 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