Observational study on the pulse waveform change of menopausal syndrome patients treated by Korean herbal medicine

Korea Institute of Oriental Medicine0 个研究点目标入组 60 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

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•Menopause patients meeting the following criteria will be included:
•1) Females between 45 and 52 years old
•2) BMI from 19.0 to 30.0 kg/m2
•3) Postmenopause (defined as at least 12 months amenorrhoea) or Perimenopause (defined as having no more than one menstrual period during the 3 months before recruitment and having follicle stimulating hormone>40 IU/L) women
•4) menopause symptoms over the last 3 months
•5) Women with moderate to severe menopausal symptoms (MRS scores = 16)
•6) Provide consent to participate in this study and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical study
•Healthy subjects meeting the following criteria will be included:
•1) Females between 45 and 52 years old
•2) BMI from 19.0 to 30.0 kg/m2
•3) a menstrual cycle of 28 ± 3 days over the last 3 months
•4) Women with moderate to severe menopausal symptoms (MRS scores < 16)
•5) Provide consent to participate in this study and sign an informed consent statement after listening to a clear explanation of the purpose and characteristics of this clinical study

•1) Subjects with hysterectomy or chemotherapy induced menopause
•2) Received hormone therapy in the past 6 months
•3) Received herbal medication in the past 2 months
•4) Subjects who took medical supplies within 4 weeks prior to the first visit : Sleep iaid drug, antidepressant, selective estrogen receptor modulator, hypocholesterolemic drug, antihypertensive drugs, antidiabetes drugs, bisphosphonate, calcitonin
•5) Suffer from cancer such as breast cancer, endometrial cancer and cervical cancer within the 5 years
•6) Clinically significant kidney or liver disease
•7) Uncontrolled hypertension, diabetes mellitus, thyroid disease
•8) weak of a stomach and accumulation
•9) severe depression and mental illness patient
•10) Confirmed or suspected history of drug or alcohol abuse
•11) Subjects sensitive to Korean herbal medicine (Dang Gui Liu Huang-Tang, ?????)
•12) History of adverse reaction to pulse tonometric device (PTD)
•13) Congenital vascular anomalies or history of wrist fracture
•14) History of another clinical study within the previous 2 months
•15) Anyone considered inappropriate for participating in this trial by the clinical trial conductors

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