None listed
Conditions
Interventions
Dietary Supplement : Subjects will undergo a 2-week run-in period and will then be randomly assigned to either the experimental or placebo group. Participants in the experimental group will orally con
Sponsors
Novarex
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 40–65 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 showing clinically significant findings requiring treatment or suggesting a possibility of progression to malignant tumors based on breast examination or vaginal ultrasonography results 3) Subjects with unknown uterine bleeding after 1 year of menopause 4) Abnormalities in liver function, renal function, or uncontrolled hypertension 5) Metabolic bone disease, femoral or vertebral fractures, other osteoporosis-related fractures or relevant medical history 6) Uncontrolled thyroid disease, diabetes mellitus, hyperlipidemia 7) Subjects who have severe mental disorders such as depression or anxiety disorder, or are currently taking psychiatric drugs such as antidepressants 8) History of severe migraine within 1 month, thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, coronary artery plastic surgery 9) Subjects currently taking or requiring the following medications: ? Medications that may affect bone metabolism within 1 month of the first visit ? Within 3 months of the first visit, hormone preparations such as female hormones, similar hormone preparations, selective estrogen receptor modulators, or drugs that may affect menopausal symptoms and bone metabolism ? Bisphosphonates or RANKL monoclonal antibodies (denosumab) within 1 year of the first visit 10) History of drug abuse, or alcoholism 11) Subjects who consumed the functional foods or oriental medicine that can affect menopausal health, blood glucose, blood lipids, blood circulation, or bone metabolism within 1 month prior to the first visit 12) Subjects who performed continuous high-intensity exercises at least 3 months prior to the first visit 13) Allergy (hypersensitivity) to any of the materials used in the study 14) Subjects who have participated in another clinical trial within 1 month prior to the first visit and have been administered investigational drugs or health functional foods, or have plans to participate in another clinical trial during the study period (excluding those who have not taken medication or health functional foods) 15) Subjects who are pregnant, lactating, or planning to become pregnant during the study period 16) Persons judged by the researcher to be inappropriate to participate in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hot flush questionnaire;Kupperman index;Menopause-Specific Quality of Life(MENQOL);Biochemical markers | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety markers | — |
Countries
Korea, Republic of
Contacts
Public ContactWonsuk Shin
Bundang CHA General Hospital
Outcome results
None listed