A verification study for improving unidentified complaints with the test food before and after menstruation: a randomized, double-blind, placebo-controlled, parallel-group trial
- Conditions
- Healthy Japanese subjects
- Registration Number
- JPRN-UMIN000033445
- 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, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method