Effects of consumption of the test food on common menstrual complaints in healthy Japanese wome
- Conditions
- Healthy Japanese
- Registration Number
- JPRN-UMIN000054202
- Lead Sponsor
- ORTHOMEDICO Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 80
Not provided
1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects 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 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 who are undergoing medical treatment or have a medical history of immune system disorders (such as multiple sclerosis, lupus erythematosus, and other autoimmune diseases) 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 dosage pill (oral contraceptive) 10. Postmenopausal subjects 11. Subjects who use or take "Foods for Specified Health Uses", "Foods with Function Claims", or other functional food/beverage 12. Subjects regularly taking medications (including herbal medicines) and supplements 13. Subjects who are allergic to medications and/or the test food related products, especially those who are allergic to pine trees 14. Subjects who are pregnant, breast-feeding or planning for pregnancy during the trial period 15. Subjects who have been enrolled in other clinical trials 28 days before the agreement to participate in this trial or those who plan to enroll in another clinical trial during the trial period 16. Subjects who are deemed ineligible to participate by the principal investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method