KCT0001458已完成未知
Clinical study for effects on menopasual symtom and blood vessel using combination of Kudzu and foxglove roots extract plus exercise
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 150
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
- 45(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)
- •5) Fasting LDL-cholesterol level = 130mg/dL
- •6) Women with low quality of the meal (recommended food score = 36)
- •7) Fasting blood glucose = 100 mg/dl
- •8) glycated hemoglobin (HbA1c) = 5.7% and = 6.4%
- •9) BMI: = 23kg/m2
排除标准
- •1) Subjects who performed constant exercises at least 3 months prior to the first visit
- •2) Subjects who cannot participate in an exercise program
- •3) Subjects with surgical or chemotherapy induced menopause 4) Subjects who have a history of breast cancer orabnormality depicted on a mammogram5) Subjects who received hormone therapy within 6 months before the first visit
- •6) Subjects who take excessive amount of isoflavones (=56 mg/day)
- •7) Subjects who consumed the functional food within 4 weeks prior to the first visit
- •8) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant,selective estrogen receptor modulator, hypocholesterolemic drug, antihypertensive drugs, antidiabetes drugs, bisphosphonate, calcitonin
- •9) Subjects who have been vaginal bleeding without diagnosis
- •10) Subjects who have a history of endometrial hyperplasia, endometrial cancer, sex steroid dependant organ tumors
- •11) Subjects who have a history of severe migraine, thromboembolism, cerebrovascular disease, cardiovascular disease within 1 year prior to the first visit
- •12) Subjects with hepatic or renal dysfunction (aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level > 2 times the upper limit of normal, Creatinine > 2.0 mg/dL)
- •13) Hypertensive subjects Systolic blood pressure(SBP)/Diastolic blood pressure(DBP) = 140/90 mmHg), subjects with thyroid disease (thyroid stimulating hormone(TSH)<0.55 uIU/mL or >4.78uIU/mL), diabetes, subjects with hyperlipidemia
- •14) drug addicts or alcoholics
- •15) Subjects sensitive to test materials
- •16) Subjects who has participated in another investigational study within 4 weeks prior to the first visit
研究者
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