None listed
Conditions
Interventions
None listed
Sponsors
Korea Institute of Oriental Medicine
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Menopause patients meeting the following criteria will be included: 1) Females between 45 and 55 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 55 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 < 8) 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
Exclusion criteria
Exclusion criteria: 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) severe depression and mental illness patient 9) Confirmed or suspected history of drug or alcohol abuse 10) Subjects sensitive to Korean herbal medicine 11) History of adverse reaction to pulse tonometric device 12) Congenital vascular anomalies or history of wrist fracture 13) History of another clinical study within the previous 2 months 14) Anyone considered inappropriate for participating in this trial by the clinical trial conductors
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulse Pressure Index (PPI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Heart Rate (HR);Pulse Depth Index (PDI);Menopause Rating Scale (MRS);Menopause-Specific Quality of Life (MENQOL);Pattern Identification Questionnaire | — |
Countries
Korea, Republic of
Contacts
Public ContactDongil Kim
Dongguk University Ilsan Oriental Hospital
Outcome results
None listed