KCT0002961招募中未知
Efficacy and Safety of Germinated & fermented Soybean extract on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
HUBIO0 个研究点目标入组 100 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
- 100
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 who are in the menopausal transition (when there is no menstruation for 3 months or more and FSH(Follicle stimulating hormone) 30 mIU/mL or more) or menopause (1 year or more after the last menstrual period)
- •2) Women with a KMI (kupperman index) score of 25 or higher
- •3) Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent form
排除标准
- •1) Women with a body mass index (BMI) greater than 30 kg / m2
- •2) Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
- •3) Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer
- •4) Women who have undergone hysterectomy
- •5) A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty
- •6) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
- •7) Women with irregular uterine bleeding after 1 year of menopause
- •8) Patients with uncontrolled hypertension(160/100mmHg or higher, after 10 minutes of clinical test subjects)
- •9) Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months)
- •10) Thyroid patients with TSH less than or equal to 0.1 µU / ml or 10 µU/ml or more
- •11) drug or alcohol abuser
- •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 there is a clinically significant abnormality in Mammography / PAP smear[BIRADS(the Breast Imaging Reporting and Data System) Category 0 or 3 or more, PAP smear is not abnormal up to ASCUS(Atypical Cells of Undetermined Significance)]
- •(However, if BI-RADS(the Breast Imaging Reporting and Data System) Category is 0, it can be registered under the judgment of PI and also BI-RADS(the Breast Imaging Reporting and Data System) Category 3 can be registered if the additional test shows that the test is positive)
- •15) 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
- •16) If PI judges that the test is inappropriate for this clinical trial
- •17) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Aspirin, Warfarin, Clopidogrel, etc.) within 3 months
- •18) Women who took medicines or health functional foods related to women's menopause within a month
- •19) Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation
研究者
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