KCT0003282招募中未知
A human study to evaluate the efficacy and safety of rice bran extract on climacteric symptoms in perimenopausal and postmenopausal women
S&D0 个研究点目标入组 60 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
- 60
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 65(Year)（—）
- 性别
- Female
入选标准
- •1) Subject who agrees to participate in the study and signs the informed consent form
- •2) Women aged 45–65 years
- •3) Post-menopausal (amenorrhea = 12 months) or peri-menopausal (amenorrhea = 3 month & follicle stimulating hormone (FSH) > 30 IU/L)
- •4) Moderate or severe menopausal symptoms (score = 15), identified by the Kupperman index
排除标准
- •1) Subjects with surgical or chemotherapy induced menopause, Subjects who have been vaginal bleeding without diagnosis
- •2) Hormone therapy within the past 6 months prior to the first visit
- •3) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids (triglycerides, cholesterol, etc.), blood pressure, blood circulation within 4 weeks prior to the first visit
- •4) Use of medication within the past 4 weeks: sleep-inducing agents, antidepressants, selective estrogen receptor modulators, antihyperlipidemic drugs, antihypertensive drugs, beta-blockers, antidiabetic drugs. However, in the case of beta-blockers, they may be included in the subject if they are expected to have no change of taking dose for one year or have no change of taking dose during the study.
- •5) History of breast cancer, endometrial hyperplasia, uterine endometrial cancer, and sex steroid dependent organ tumors or subjects with clinically significant abnormality in thyroid function test, mammography, or pelvic ultrasound
- •6) Abnormality in renal and liver function (eGFR < 60; ALT or AST > the upper limit of normal levels x 2.5), uncontrolled hypertension (systolic blood pressure (SBP)/diastolic blood pressure (DBP) >160/100 mmHg), thyroid disease, diabetes mellitus, hyperlipidemia
- •7) History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular conditions within 1 year
- •8) Beck Depression Inventory score =13, = 29
- •9) History of drug abuse, or alcoholism
- •10) Subjects who performed continuous high-intensity exercises at least 3 months prior to the first visit (=10 hours/week)
- •11) Allergy (hypersensitivity) to any of the materials used in the study
- •12) Subject who participated in other clinical trial within 1 month
- •13) Other cases considered inappropriate for the clinical trial by the investigator
研究者
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