KCT0002616尚未招募未知
A human study to evaluate safety and effectiveness of Tetragonia tetragonoides extract on menopausal symptoms in postmenopausal women
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 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) The particioants who give informed consent before the start
- •2) 45~60 years old
- •3) Postmenopause (defined as at least 12 months amenorrhoea) or perimenopause (defined as having no more than one menstrual period during the 3 months before recruitment and having follicle stimulating hormone>40 IU/L) women
- •4) Women with moderate to severe menopausal symptoms (Kupperman index total score = 20)
排除标准
- •1) Subjects with surgical or chemotherapy induced menopause, a history of breast cancer or abnormal vaginalbleeding without diagnosis
- •2) Subjects who received hormone therapy within 6 months before the first visit
- •3) Subjects who consistently consumed the functional food related to postmenopause, bone health, blood glucose, blood lipid(cholesterol, triglyceride), blood pressure or blood flow within 1 month prior to the first visit
- •4) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, antihyperlipidemic agent, antihypertensive agent, antidiabetic agent, bisphosphonate or calcitonin
- •5) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors
- •6) Subjects who have a history of severe migraine, thromboembolic disorders, cerebrovascular disorders, cardiovascular disease within 1 year prior to the first visit
- •7) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 3 times the upper limit of normal, Creatinine > 2.0 mg/dL), uncontrolled hypertension (systolic blood pressure/diastolic blood pressure > 140/90 mmHg), thyroid disease, diabetes or hyperlipidemia
- •8) drug addicts or alcoholics
- •9) Subjects who performed constant severe exercises at least 3 months prior to the first visit
- •10) Sensitive to test materials
- •11) Subjects who has participated in another clinical trial within 1 month prior to the first visit
- •12) Any condition that the principal investigator believes may put the subjects at undue risk
研究者
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