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

Not Applicable

Completed

Conditions: Diseases of The genitoruinary system

Registration Number: KCT0002070

Lead Sponsor: Korea Institute of Oriental Medicine

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 60

Inclusion Criteria

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

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) 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Pressure Index (PPI)

Secondary Outcome Measures

Name	Time	Method
Menopause-specific quality of life (MENQOL);Korean medicine pattern identification questionnaire;Heart Rate (HR);Pulse Depth Index (PDI);Pulse Volume Index (PVI)