Study on Efficacy and Safety of Fabaton Soybean extract for menopausal syndromes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0003823
- Lead Sponsor
- Pusan National University Korean Medicine Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 90
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method KI (Kupperman index)
- Secondary Outcome Measures
Name Time Method MENQOL (Menopause-specific Quality of Life questionnaire);Deoxypyridinoline, NTx(N-terminal telopeptide), CTx(C-terminal telopeptide);Osteocalcin, bone-specific alkaline phosphatase