None listed
Conditions
Interventions
Dietary Supplement : Subjects will be randomly allocated to placebo or experimental group and take 2 tablets once a day for 12 weeks.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Subject who agrees to participate in the study and signs the informed consent form 2) Women aged 45–65 years 3) Post-menopausal (amenorrhea = 12 months) or peri-menopausal (amenorrhea = 3 month & follicle stimulating hormone (FSH) > 30 IU/L) 4) Moderate or severe menopausal symptoms (Kupperman index score = 15) 5) Subject with an average daily hot flash score of 10 or higher for the past 1 week
Exclusion criteria
Exclusion criteria: 1) Subjects who have surgical or chemotherapy induced menopause, vaginal bleeding without diagnosis 2) Subjects with a history of endometrial hyperplasia, cervical cancer, endometrial cancer, breast cancer or breast disease, sex hormone-related cancer, etc., or abnormal findings in breast examination results or vaginal ultrasonography 3) Subjects with unknown uterine bleeding after 1 year of menopause 4) Abnormality in renal or liver function, uncontrolled hypertension 5) Uncontrolled thyroid disease, diabetes mellitus, hyperlipidemia 6) Subjects who have severe mental disorders such as depression or anxiety disorder, or are currently taking psychiatric drugs such as antidepressants 7) History of Severe migraine within 1 year, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, coronary artery plastic surgery 8) Within 3 months of the first visit, hormone preparations such as female hormones, similar hormone preparations, selective estrogen receptor modulators, drugs that may affect menopausal symptoms was used 9) History of drug abuse, or alcoholism 10) Subjects who consumed the functional food or oriental medicine that can affect menopausal health, blood glucose, blood lipids, blood circulation within 1 months prior to the first visit 11) Subjects who performed continuous high-intensity exercises at least 1 months prior to the first visit 12) Allergy (hypersensitivity) to any of the materials used in the study 13) Subject who participated in other clinical trial within 1 month 14) Subjects who are pregnant or planning to become pregnant 15) Other cases considered inappropriate for the clinical trial by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kupperman index ;hot flush questionnaire;MENQOL;biochemical markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety markers | — |
Countries
Korea, Republic of
Contacts
Public ContactBeLong Cho
Seoul National University Hospital
Outcome results
None listed