Observational study on the pulse waveform change of menopausal syndrome patients treated by Gyejibokryeong-hwa
- Conditions
- Diseases of The genitoruinary system
- Registration Number
- KCT0003400
- Lead Sponsor
- Korea Institute of Oriental Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 70
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
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
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pulse Pressure Index (PPI)
- Secondary Outcome Measures
Name Time Method Heart Rate (HR);Pulse Depth Index (PDI);Menopause Rating Scale (MRS);Menopause-Specific Quality of Life (MENQOL);Pattern Identification Questionnaire