KCT0007528尚未招募未知
A human study to evaluate the efficacy and safety of herbal complex extract NS2107 on climacteric symptoms in menopausal 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
- 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 (Kupperman index score = 15)
- •5) Subject with an average daily hot flash score of 10 or higher for the past 1 week
排除标准
- •1) Subjects who have surgical or chemotherapy induced menopause, vaginal bleeding without diagnosis
- •2) Subjects with a history of endometrial hyperplasia, cervical cancer, endometrial cancer, breast cancer or breast disease, sex hormone-related cancer, etc., or abnormal findings in breast examination results or vaginal ultrasonography
- •3) Subjects with unknown uterine bleeding after 1 year of menopause
- •4) Abnormality in renal or liver function, uncontrolled hypertension
- •5) Uncontrolled thyroid disease, diabetes mellitus, hyperlipidemia
- •6) Subjects who have severe mental disorders such as depression or anxiety disorder, or are currently taking psychiatric drugs such as antidepressants
- •7) History of Severe migraine within 1 year, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, coronary artery plastic surgery
- •8) Within 3 months of the first visit, hormone preparations such as female hormones, similar hormone preparations, selective estrogen receptor modulators, drugs that may affect menopausal symptoms was used
- •9) History of drug abuse, or alcoholism
- •10) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids, blood circulation within 1 months prior to the first visit
- •11) Subjects who performed continuous high-intensity exercises at least 1 months prior to the first visit
- •12) Allergy (hypersensitivity) to any of the materials used in the study
- •13) Subject who participated in other clinical trial within 1 month
- •14) Subjects who are pregnant or planning to become pregnant
- •15) Other cases considered inappropriate for the clinical trial by the investigator
研究者
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