None listed
Conditions
Interventions
Dietary Supplement : Both intervention and comparison groups takes test material or placebo one tablet at a time, twice a day by oral administration. Intervention material is Rubus coreanus Miguel and
Sponsors
KolmarBNH
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged 20-40 years 2. Women in menopausal period (amenorrhea 12 months in a row) OR menopaupausal transition period (amenorrhea 3 months in a row AND FSH > 40 IU/L) 3. Women with menopausal symptoms moderate or above degree (Kupperman Index = 20) 4. Women signed the informed consent form
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormality in mammography (breast imaging-reporting and data system category (BI-RADS) 0 OR above 3. Nevertheless, BI-RADS 0 can be enrolled by the researchers’ decision) 2. Endometrial thickness above 5 mm by vaginal ultrasonography 3. History of surgery- or chemotherapy induced amenorrhea, undiagnosed vaginal hemorrhage 4. History of hormone therapy in 6 months before the first visit 5. History of continuous taking health functional food or herbal medicine affecting menopausal health, blood lipids (neutral fat, cholesterol, etc.), blood pressure or blood flow in 1 month before the first visit 6. Medicine taking history of sleep inducer, antidepressant, selective estrogen receptor modulator, lipid-lowering drugs, antihypertensive drugs 7. History of endometrial hyperplasia, uterine endometrial cancer, sex steroid dependet organ tumors 8. History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular condition within 1 year before the first visit 9. Uncontrolled underlying disease including liver or renal function failure (ALT or AST above 3 fold higher than reference level, creatinine > 2.0 mg/dL), hypertension (SBP > 160 mmHg or DBP > 100 mmHg), thyroid disease, diabetes, hyperlipidemia 10. Addicted drugs or alcohol 11. Habitual taking of large amount of isoflavone 12. Continuous intensive exercise within 3 months before the first visit (=10 hours/week) 13. Hypersensitivity to the test material or ingredients in the test material 14. Participated in other clinical research within 1 month before the first visit 15. Inappropriate for the test by the researchers’ decision
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman Index | — |
Secondary
| Measure | Time frame |
|---|---|
| menopause rating scale, MRS;lipid profile (total cholesterol, triglyceride, LDL-C, HDL-C);laboratory test, vital signs;follicle stimulating hormone, FSH;endometrial thickness;Estradiol, E2;luteinizing hormone | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon Mi Shin
Semyung University
Outcome results
None listed