Healthy Japanese
Conditions
Interventions
Duration: Approximately 16 weeks (menstrual cycle x 4 = 100-152 days) Test food: Pycnogenol (R) Administration: After the enrollment is confirmed, take 2 capsules per day with water or warm water, s
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. Female 3. Subjects aged 20 ~ 40 4. Healthy subjects 5. Subjects who have common menstrual complaints 6. Subjects whose menstrual cycle is between 25 and 38 days 7. Subjects whose lasting period of the menstruation is between 3 and 7 days 8. Subjects whose score of Neg Affect in the MDQ (before menstruation) is high at Scr
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The measured value of the score of Neg Affect in the Menstrual Distress Questionnaire (MDQ) (before menstruation) at the 2nd examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The amount of change and rate of change of the score of Neg Affect in the MDQ (before menstruation) between Scr and the 2nd examination. 2. The measured value of the score of Neg Affect in the MDQ (before menstruation) at the 1st examination, the amount of change and rate of change of the score of Neg Affect in the MDQ (before menstruation) between Scr and the 1st examination. 3. The measured value of the score of Neg Affect in the MDQ (during and after menstruation) at the 1st and the 2nd examination, the amount of change and rate of change of the score of Neg Affect in the MDQ (during and after menstruation) between Scr and the 1st or the 2nd examination. 4. The measured value of the score of each scale (Pain, Water Reten, Auto React, Impair Conc, Behave Change, Arousal, Control) in the MDQ (before, during and after menstruation) at the 1st and the 2nd examination, the amount of change and rate of change of the score of the in the above scales in the MDQ (before, during and after menstruation) between Scr and the 1st or the 2nd examination. 5. Each item in the MDQ at the 1st and the 2nd examination. 6. The measured value of the score of each item of the Premenstrual Tension Syndrome-Visual Analogue Scale (PMTS-VAS) at the 1st and the 2nd examination, the amount of change and rate of change of each item of the PMTS-VAS between Scr and the 1st or the 2nd examination. | — |
Countries
Japan
Contacts
Public ContactNaoko Suzuki
ORTHOMEDICO Inc. R&D Department
Outcome results
None listed