KCT0003823招募中未知
Efficacy and Safety of Fabaton Soybean extract on menopausal symptoms; A single-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
Pusan National University Korean Medicine Hospital0 个研究点目标入组 90 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 40(Year) 至 65(Year)（—）
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
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