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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002070
Enrollment
60
Registered
2016-09-21
Start date
2016-08-08
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Menopause patient: Dang Gui Liu Huang-Tang 6 grams per time orally 3 times per day for 4 weeks. Control: Non-patient group did not receive any intervention.

Sponsors

Korea Institute of Oriental Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pulse Pressure Index (PPI)

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactHyun Ho Kim

Kyung Hee University

mechante@hanmail.net+82-2-958-9242

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026