KCT0005546进行中（未招募）未知
Randomized, Double-blinded, Placebo-controlled Study of Rubus coreanus Miquel and Astragalus membranaceus Bunge extract mixture to Evaluate Efficacy and Safety on Healthy Subjects with Postmenopausal Syndrome
KolmarBNH0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 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 60(Year)（—）
- 性别
- Female
入选标准
- •1. Women aged 20-40 years
- •2. Women in menopausal period (amenorrhea 12 months in a row) OR menopaupausal transition period (amenorrhea 3 months in a row AND FSH > 40 IU/L)
- •3. Women with menopausal symptoms moderate or above degree (Kupperman Index = 20)
- •4. Women signed the informed consent form
排除标准
- •1. Clinically significant abnormality in mammography (breast imaging-reporting and data system category (BI-RADS) 0 OR above 3. Nevertheless, BI-RADS 0 can be enrolled by the researchers’ decision)
- •2. Endometrial thickness above 5 mm by vaginal ultrasonography
- •3. History of surgery- or chemotherapy induced amenorrhea, undiagnosed vaginal hemorrhage
- •4. History of hormone therapy in 6 months before the first visit
- •5. History of continuous taking health functional food or herbal medicine affecting menopausal health, blood lipids (neutral fat, cholesterol, etc.), blood pressure or blood flow in 1 month before the first visit
- •6. Medicine taking history of sleep inducer, antidepressant, selective estrogen receptor modulator, lipid-lowering drugs, antihypertensive drugs
- •7. History of endometrial hyperplasia, uterine endometrial cancer, sex steroid dependet organ tumors
- •8. History of severe migraine headache, thromboembolic disorders, cerebrovascular disorders, serious cardiovascular condition within 1 year before the first visit
- •9. Uncontrolled underlying disease including liver or renal function failure (ALT or AST above 3 fold higher than reference level, creatinine > 2.0 mg/dL), hypertension (SBP > 160 mmHg or DBP > 100 mmHg), thyroid disease, diabetes, hyperlipidemia
- •10. Addicted drugs or alcohol
- •11. Habitual taking of large amount of isoflavone
- •12. Continuous intensive exercise within 3 months before the first visit (=10 hours/week)
- •13. Hypersensitivity to the test material or ingredients in the test material
- •14. Participated in other clinical research within 1 month before the first visit
- •15. Inappropriate for the test by the researchers’ decision
研究者
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