None listed
Conditions
Interventions
Dietary Supplement : Take a total of 3 capsules once or twice a day of test food (300 mg/day as a complex such as Baeksuo extract) or placebo
Sponsors
Korea University Anam Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) a woman over forty and under sixty 2) A person who falls under one or more of the following criteria: ? Menopause (more than a year after the last period) ? Peripheral menopause (no menstruation for more than 3 months or FSH 30 mIU/mL) ? FSH not less than 30 mIU/mL (without uterus) 3) A person who has an MRS score of 9 points or more in visit 1 and has an average number of upper body fever (heat) symptoms per day in the period between visit 1 and visit 2 or more 4) A person who agrees to participate in the human body application test and signs a written consent form prior to the commencement of the human body application test
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urological, musculoskeletal, infectious diseases, and malignant tumors (except endometrial cancer, breast cancer, or sex hormone-related cancers, 5 years after cure can participate) 2) Those whose body mass index (BMI) exceeds 30 kg/m2 3) A person who has a past history of endometrial proliferation, endometrial cancer, breast cancer, or sex hormone-related cancer 4) Those with undiagnosed uterine bleeding after one year of menopause 5) A person who drinks alcohol equivalent to an average of 20 g or more (140 g/week) per day for women within four weeks of visiting 6) A person who has severe migraine within one year as of Visit 1, has been diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, and unstable angina, or has a history of performing coronary artery plastic surgery 7) Those who have severe mental illnesses such as depression and anxiety disorders, or are currently taking psychiatric neurological drugs (SSRI, Gabapentin, Benzodiazepine, etc.) such as antidepressants and sleeping pills 8) Within 3 months of visit 1, thyroid hormone drugs, clonidine, anticoagulants, anti-thrombotic drugs (Wafarin, clopidogrel, etc.), osteoporosis treatments (Selective Estrogen Receptor Modulator, Bisphosphonate, etc.), contraceptives, etc 9) A person who has used hormone preparations such as female hormones or similar hormone preparations (Western Equestrian, St. John'sworth, Red Clover, Agnuscastus fruit, etc.) within three months as of Visit 1 10) A person who has taken medicines or health functional foods related to menopause for women within one month (30 days) as of visit 1 11) If clinically significant abnormalities (BI-RADS Category 0 or 3 or higher, PAP-smear has no abnormalities up to ASCUS) are identified in mammography/PAP smear (However, if it is BI-RADS Category 0, it can be registered after checking the additional test results) 12) A person whose creatinine is twice or more than the upper limit of the institution's normal limit 13) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution; 14) Patients with uncontrolled hypertension (as measured after stabilizing for 10 minutes with systolic blood pressure of 160 mmHg or more or diastolic blood pressure of 100 mmHg or more) 15) Diabetes patients whose blood sugar is not controlled (if new drugs are started due to diabetes within 3 months of visit or more than 180 mg/dL of fasting blood sugar) 16) Those with a TSH of not more than 0.1 µIU/mL or not more than 10 µIU/mL 17) A person who has participated in other interventional clinical trials (including human application tests) within one month of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test 18) A person who is sensitive to or allergic to food ingredients for this human body application test; 19) A person who is deemed inappropriate by the tester for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of KI | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual item scores (11 items of KI, dry items) of Modified KI;MENQOL-K ;Upper body sweating (heat) score (number of symptoms, degree) ;blood lipid(Total Cholesterol, Triglyceride, HDL-Cholesterol, LDLCholesterol) ;Blood ALP, OC, CTx ;Urine NTx | — |
Countries
Korea, Republic of
Contacts
Public ContactTak Kim
Korea University
Outcome results
None listed