KCT0002254招募中未知
Efficacy and safety of HPC-03 for menopausal symptom: 12 weeks, multicenter, randomized, double-blind, placebo-controlled study
Hanpoong Pharm & Foods0 个研究点目标入组 150 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
- 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
- 40(Year) 至 60(Year)（—）
- 性别
- Female
入选标准
- •1) Women 40 to 60 years old who have passed one year or more since the last menstrual period
- •2) Women with a kupperman index score of 20 or higher
- •3) Women who have agreed to participate in this trial before the start of the clinical trial and who have written an informed consent
排除标准
- •1) Women with a body mass index (BMI) greater than 30 kg / m2
- •2) Women using hormone preparations such as female hormones or similar hormone preparations (plant extracts, etc.) within 3 months
- •3) Women with a history of endometrial hyperplasia, uterine cancer, endometrial cancer, breast or breast disease, sex hormone related cancer
- •4) A woman with a history of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty
- •5) Women with severe mental illnesses such as depression and anxiety disorder, or those currently taking psychotropic drugs such as antidepressants
- •6) Women with irregular uterine bleeding after 1 year of menopause
- •7) Patients with uncontrolled hypertension (160 / 100mmHg or higher, after 10 minutes of clinical test subjects)
- •8) Patients with diabetes whose blood sugar is not controlled (fasting glucose 180 mg / dL or diabetes mellitus within 3 months)
- •9) Those with uncontrolled thyroid disease (those who are considered to be able to participate in this trial by the tester can participate)
- •10) drug or alcohol abuser
- •11) If ALT(Alanine transaminase ) or AST(Aspartate transaminase ) exceeds 3 times the normal upper limit of the research institute
- •12) If creatinine exceeds twice the upper limit of the normal level of research institute
- •13) Mammography / PAP(Papanicolaou) smear If a clinically significant abnormality [ Breast imaging-reporting and data system (BIRADS) Category 0 or 3 or more, PAP smear is not abnormal up to ASCUS(Atypical Cells of Undetermined Significance)] is confirmed (BI-RADS Category 0, )
- •14) If you have participated in another clinical trial within one month of the start of this trial or plan to participate in another clinical trial during the trial period
- •15) If the tester judges that the test is inappropriate for this clinical trial
- •16) Women using thyroid hormone preparations, clonidine, anticoagulants or antithrombotic agents (Warfarin, Clopidogrel, etc.) within 3 months
- •17) Women who took medicines or health functional foods related to women's menopause within a month
研究者
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