None listed
Conditions
Interventions
Dietary Supplement : In the case of the test group, four tablets once a day and once a day were taken with water after dinner, and in the case of the placebo group, drugs with the same shape and taste
Sponsors
Neumed
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 40-60 years 2) A person who falls under one or more of the following criteria ? Menopause (more than one year after the last period) ? Menopause (no menstruation for more than 3 months or FSH 30 mIU/mL) 3)A person who has an MRS score of 9 or more in Visit 1, and has an average facial flush score of 10 or more per day by recalling within a week based on Visit 1 4) Subjects who agree to participated in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) Those currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urology, nervous, musculoskeletal, infectious diseases, and malignant tumors (except for endometrial cancer, breast cancer, or sex hormone-related cancers can participate) 2)BMI greater than 30 kg/m2 3) A person who has a history of endometrial proliferation, endometrial cancer, breast cancer, or sex hormone-related cancer 4) Persons with undiagnosed malformed uterine hemorrhage after one year of menopause 5) A person who drinks alcohol equivalent to an average of at least 20 g (140 g/week) per day within 4 weeks of visiting 6) Severe migraines within one year of visit, thromboembolism, cerebrovascular disease, A person who has been diagnosed with myocardial infarction or unstable angina, or has a history of performing coronary artery plastic surgery 7) A person who has severe mental illness such as depression or anxiety disorder, or is currently taking psychiatric drugs such as antidepressants and sleeping pills (SSRI, Gabapentin, Benzodiazepine, etc.) 8) Thyroid hormone drugs, Clonidine, anticoagulants, and the like within 3 months of visit, Anti-thrombotic agents (Wafarin, Clopidogrel, etc.), osteoporosis treatments (Selective Estrogen Receptor Modulator, bisphosphonate, etc.), contraceptive use 9) A person who has used hormone preparations such as female hormones or similar hormone preparations (Western horseback riding, St. John's Wort, red clover, Agnus castus fruit, etc.) within three months of visiting 10) A person who has taken drugs or health functional foods related to women's menopause within one month (30 days) as of one visit 11) Clinically significant abnormalities on mammography (BI-RADS Category 0 or 3 Above) is confirmed (However, if BI-RADS Category 0, it can be registered after checking additional inspection results) 12) Those whose creatine is more than twice the normal upper limit of the implementing agency 13) A person whose AST (GOT) or ALT (GPT) is more than three times the upper limit of the organization 14) Patients with uncontrolled hypertension (at least 160 mmHg of systolic blood pressure or at least 100 mmHg of diastolic blood pressure, measured after 10 minutes of stabilization of subjects) 15) Diabetes patients whose blood sugar is not controlled (if the drug is newly started due to diabetes on an empty blood sugar of 180 mg/dL or higher or within 3 months of visit) 16) A person who has taken drugs (Statins, Fibrates, Ezetimibe, Niacin, Probucol, Bile Acid Sequestrants, etc.) that can affect lipid metabolism within 4 weeks of visiting 17) Those with a TSH of 0.1 µIU/mL or less or 10 µIU/mL or more 18) A person who has participated in another interventional clinical trial (including human application test) within one month of visit, or plans to participate in another interventional clinical trial (including human application test) after the start of this human application test 19) A person who is sensitive or allergic to food ingredients for this human body application test 20) A person who judges that the tester is inappropriate for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of KI | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual item score of modified KI;Score of MRS;Total Cholesterol, Triglyceride, HDL-Cholesterol, LDLCholesterol;Alkaline Phosphatase;facial flush score | — |
Countries
Korea, Republic of
Contacts
Public Contactkwon hanseul
Semyung University Oriental Medicine Hospital
Outcome results
None listed