KCT0003211已完成未知
Efficacy and Safety of Lactobacillus acidophilus YT1 Probiotics on menopausal symptoms; A 12week, Multi-center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 80
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 60(Year)（—）
- 性别
- Female
入选标准
- •1)40 to 60 year-old women with FSH 30 mIU / ml or more who have passed one year since the last menstrual period or who have no uterus
- •2) Women with a kupperman index score of 20 or higher
- •3) Women who have agreed to participate in this human body test before the start of the human body test and who have written an informed consent
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 cancer or breast disease, sex hormone related cancer
- •4) A woman with a history of severe migraine within the past year or who has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or underwent coronary angioplasty
- •5) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
- •6) Women with irregular uterine bleeding after 1 year of menopause
- •7) Patients with uncontrolled hypertension (160 /100mmHg or more, After 10 minutes of stabilization)
- •8) Uncontrolled diabetes mellitus patients (fasting blood sugar more than 180mg/dL or starting a new drug due to diabetes within 3 months)
- •9) Patients with thyroid disease whose TSH is less than or equal to 0.1 µU / ml or more than 10 µU / ml
- •10) drug or alcohol abuser
- •11) If ALT or AST exceeds 3 times the normal upper limit of the research institute
- •12) Creatinine exceeds twice the normal upper limit of research institute
- •13) Mammography / PAP smear When a clinically significant abnormality (BI-RADS Category 0 or 3 or more, PAP smear is absent up to ASCUS) is confirmed
- •14) Have participated or planned to participate in other clinical trials within the past month
- •15) If the tester judges that the test is inappropriate for this human body test
- •16) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clipidogrel, etc.) within 3 months
- •17) Women who took medicines or health functional foods related to women's menopause within a month
- •18) Women who have taken probiotics within 2 weeks of screening
- •19) Those taking or administering a therapeutic agent for osteoporosis, such as a bisphosphonate preparation
研究者
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