KCT0009162已完成Unknown
A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of NVP-1905 on Menopausal Symptoms of Women
Soonchunhyang University Medical Center0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 45(Year) 至 60(Year)（—）
- 性别
- Female
入选标准
- •1) Women who are 45 years of age or older and 60 years of age who are in menopause (more than 1 year after their last menstrual period) or in the menopausal transition period (no menstruation for more than 3 months and FSH greater than 30 mIU/mL)
- •2) Menopause Rating Scale (MRS) score of 9 or higher at Visit 1
- •3) Subjects with an average of 5 or more hot flashes per day in the run-in period between Visit 1 and Visit 2
- •4) A person who agrees to participate in the human body application test before the start of the human body application test and has prepared an informed consent form
排除标准
- •1) Body Mass Index (BMI) greater than 30kg/m2
- •2) Subjects who have used female menopause-related medicines (hormonal preparations such as female hormones or similar hormone preparations (plant extracts, etc.)} within 3 months of Visit 1
- •3) Those who have uterine cancer, endometrial cancer, breast cancer, or sex hormone-related cancer, etc., or have a history of
- •4) Patients who have severe migraine, thromboembolism, cerebrovascular disease, myocardial infarction, or unstable angina pectoris within 1 year from the date of Visit 1, or have a history of coronary angioplasty
- •5) Those who are currently taking psychoneurological drugs such as antidepressants and sleeping pills
- •6) Those who have uterine bleeding of unknown cause after 1 year of menopause
- •7) Patients with uncontrolled hypertension (systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher, measured after 10 minutes of rest for human body test subjects)
- •8) Patients with uncontrolled diabetes (fasting blood glucose greater than 180 mg/dl)
- •9) Patients with uncontrolled hyperlipidemia (triglycerides greater than or equal to 300 mg/dl or total cholesterol greater than or equal to 300 mg/dl)
- •10) Patients with thyroid disease with TSH less than 0.1 µU/ml or more than 10 µU/ml
- •11) Drug or alcohol abusers
- •12) ALT or AST exceeding 3 times the normal upper limit of the laboratory
- •13) Creatinine exceeds 2 times the normal limit of the laboratory
- •14) If clinically significant abnormalities (BI-RADS Category 0 or 3 or higher) are confirmed on Mammography/PAP smear (However, BI-RADS Category 0 can be registered after confirmation of additional test results, and in the case of PAP smear, it can be registered up to ASCUS)
- •15) Subjects who have used thyroid hormone drugs, clonidine, anticoagulants, antithrombotic drugs, or osteoporosis drugs (selective estrogen receptor modulators, bisphosphonates, etc.) within 3 months of Visit 1
- •16) Those who have continuously consumed health functional foods such as probiotics and prebiotics within 1 week of visit 1
- •17) Those who have taken obesity medication, hyperlipidemia treatment, osteoarthritis medication, vitamin D, and antibiotics within 1 month of Visit 1 (However, in the case of hyperlipidemia treatment, those who have taken it steadily for 3 months prior to Visit 1 can participate in the study)
- •18) Female menopause (pomegranate, baeksuo, schisandra extract, red ginseng, etc.), blood circulation, blood lipids, joint/bone health improvement health functional foods and herbal medicines within 1 month of Visit 1
- •19) Continuous intense exercise within 3 months based on Visit 1 (>10 hours/week) 20) Persons who are sensitive or allergic to the food for this human body application test
- •21) Participants who have participated in other interventional clinical trials (including clinical trials) within 1 month of the start of this clinical trial or who plan to participate in other interventional clinical trials (including clinical trials) after the start of this clinical trial
- •22) Those who are pregnant or planning to become pregnant during this clinical trial or those who are breastfeeding 23) Those who are judged to be inappropriate for this human body application test by the examiner
研究者
相似试验
招募中
不适用
A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of HDB1258 on Improving Immune FunctioKCT0008204Seoul National University Bundang Hospital100
招募中
不适用
Clinical Trial for the Evaluation of the Efficacy and Safety of AGE on Reducing Serum Uric AcidKCT0005388H Plus Yangji Hospital56
已完成
不适用
A 8 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of OFE on Memory Improvement of AdolescentKCT0008170Konkuk University Medical Center56
招募中
不适用
A 8 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of CAEC on Immune FunctioKCT0007273AEKYUNG Industry100
招募中
不适用
A Clinical Trial for the Evaluation of the Efficacy and Safety of Platycodon grandiflorum extract mixture on improvement on stressFactors influencing health status and contact with health servicesKCT0007161Sungkyunbiotech150