None listed
Conditions
Interventions
Dietary Supplement : Take the test food (NVP-1905) once a day, 1 stick pouch once a time with plenty of water
Sponsors
Soonchunhyang University Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women who are 45 years of age or older and 60 years of age who are in menopause (more than 1 year after their last menstrual period) or in the menopausal transition period (no menstruation for more than 3 months and FSH greater than 30 mIU/mL) 2) Menopause Rating Scale (MRS) score of 9 or higher at Visit 1 3) Subjects with an average of 5 or more hot flashes per day in the run-in period between Visit 1 and Visit 2 4) A person who agrees to participate in the human body application test before the start of the human body application test and has prepared an informed consent form
Exclusion criteria
Exclusion criteria: 1) Body Mass Index (BMI) greater than 30kg/m2 2) Subjects who have used female menopause-related medicines (hormonal preparations such as female hormones or similar hormone preparations (plant extracts, etc.)} within 3 months of Visit 1 3) Those who have uterine cancer, endometrial cancer, breast cancer, or sex hormone-related cancer, etc., or have a history of 4) Patients who have severe migraine, thromboembolism, cerebrovascular disease, myocardial infarction, or unstable angina pectoris within 1 year from the date of Visit 1, or have a history of coronary angioplasty 5) Those who are currently taking psychoneurological drugs such as antidepressants and sleeping pills 6) Those who have uterine bleeding of unknown cause after 1 year of menopause 7) Patients with uncontrolled hypertension (systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher, measured after 10 minutes of rest for human body test subjects) 8) Patients with uncontrolled diabetes (fasting blood glucose greater than 180 mg/dl) 9) Patients with uncontrolled hyperlipidemia (triglycerides greater than or equal to 300 mg/dl or total cholesterol greater than or equal to 300 mg/dl) 10) Patients with thyroid disease with TSH less than 0.1 µU/ml or more than 10 µU/ml 11) Drug or alcohol abusers 12) ALT or AST exceeding 3 times the normal upper limit of the laboratory 13) Creatinine exceeds 2 times the normal limit of the laboratory 14) If clinically significant abnormalities (BI-RADS Category 0 or 3 or higher) are confirmed on Mammography/PAP smear (However, BI-RADS Category 0 can be registered after confirmation of additional test results, and in the case of PAP smear, it can be registered up to ASCUS) 15) Subjects who have used thyroid hormone drugs, clonidine, anticoagulants, antithrombotic drugs, or osteoporosis drugs (selective estrogen receptor modulators, bisphosphonates, etc.) within 3 months of Visit 1 16) Those who have continuously consumed health functional foods such as probiotics and prebiotics within 1 week of visit 1 17) Those who have taken obesity medication, hyperlipidemia treatment, osteoarthritis medication, vitamin D, and antibiotics within 1 month of Visit 1 (However, in the case of hyperlipidemia treatment, those who have taken it steadily for 3 months prior to Visit 1 can participate in the study) 18) Female menopause (pomegranate, baeksuo, schisandra extract, red ginseng, etc.), blood circulation, blood lipids, joint/bone health improvement health functional foods and herbal medicines within 1 month of Visit 1 19) Continuous intense exercise within 3 months based on Visit 1 (>10 hours/week) 20) Persons who are sensitive or allergic to the food for this human body application test 21) Participants who have participated in other interventional clinical trials (including clinical trials) within 1 month of the start of this clinical trial or who plan to participate in other interventional clinical trials (including clinical trials) after the start of this clinical trial 22) Those who are pregnant or planning to become pregnant during this clinical trial or those who are breastfeeding 23) Those who are judged to be inappropriate for this human body application test by the examiner
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flashes score (number of symptoms, severity) | — |
Secondary
| Measure | Time frame |
|---|---|
| (modified) KI(Kupperman Index);MRS(Menopause Rating Scale);MENQOL;Blood ALP, OC;Urine NTx;Total Cholesterol, LDL-Cholesterol, HDLCholesterol, Triglyceride;Nugent score, PCR;Intravaginal and fecal flora changes | — |
Countries
Korea, Republic of
Contacts
Public ContactTaeHee Kim
Soon Chun Hyang University
Outcome results
None listed