None listed
Conditions
Interventions
Dietary Supplement : Experimental group: Take 2 tablets, Twice a day, with enough water (700mg/tablet, daily intake of 2800mg of test food)
Control group: Take 2 tablets, Twice a day, with enough wat
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women 40 to 65 years of age 2. Women who are in the menopause (1 year or more after the last menstrual period) 3. Women with a KMI (kupperman index) score of 15 or higher 4. Women after 6 weeks post bilateral oophorectomy with or without hysterectomy on screening day 5. Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent form 6. Women who can follow-up during clinical trials 7. Women who are not included in the exclusion criteria
Exclusion criteria
Exclusion criteria: 1. If there is a clinically significant abnormality in Mammography [BIRADS(the Breast Imaging Reporting and Data System) Category 0 or 3 or more (However, if BI-RADS(the Breast Imaging Reporting and Data System) Category is 0, it can be registered under the judgment of PI). 2. Women exceeding 5mm in endometrial thickness by sonography. 3. Women received HRT(hormone replacement therapy) within 3 months of the screening date. 4. Women who have medication use due to hypothyroidism or hyperthyroidism within 3 months of the screening date. 5. Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast cancer or breast disease, sex hormone related cancer. 6. women with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty 7. Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants 8. Women with irregular uterine bleeding after 1 year of menopause 9. Patients with uncontrolled hypertension(160/100mmHg or higher, after 10 minutes stabilization of clinical test subjects) 10. Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months) 11. Patients with uncontrolled thyroid disease (those who are considered to be able to participate in this test by the tester can participate) 12. If ALT(Alanine transaminase) or AST(Aspartate transaminase ) exceeds 3 times the normal upper limit of the research institute 13. If Creatinine exceeds twice the upper limit of the normal level of research institute 14. If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period 15. Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Aspirin, Warfarin, Clopidogrel, etc.) within 3 months 16. Women who took medicines or health functional foods related to women's menopause within a month 17. drug or alcohol abuser 18. Pregnant women, lactating women, and women who are in potential pregnancy 19. Those who are accommodated in social facilities such as social welfare facilities 20. If PI judges that the person is inappropriate for this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| KI (Kupperman index) | — |
Secondary
| Measure | Time frame |
|---|---|
| MENQOL (Menopause-specific Quality of Life questionnaire);Deoxypyridinoline, NTx(N-terminal telopeptide), CTx(C-terminal telopeptide);Osteocalcin, bone-specific alkaline phosphatase | — |
Countries
Korea, Republic of
Contacts
Public Contactkyung park
Pusan National University Korean Medicine Hospital
Outcome results
None listed