None listed
Conditions
Interventions
Dietary Supplement : Subject were randomly assigned to either RHE (n=50) or placebo groups (n=50), and were administered 500 mg of the RHE or placebo, respectively, daily for 12 weeks.
Sponsors
Naturetech
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women aged 45-65 years 2) Postmenopausal women (at least 12 months of amenorrhea) or at least 6 weeks after bilateral oophorectomy 3) Estradiol < 30 pg/ml and FSH = 40 mIU/ml 4) Kupperman's index score = 20 5) Subjects who agree to participated in the study and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1) Women who is taking hormone therapy within 3 months prior to the trial 2) Menopausal women due to hysterectomy or chemotherapy 3) History of endometrial proliferation, endometrial cancer, breast cancer, or sex hormone-related cancer 4) Abnormal uterine bleeding after 1 year of menopause 5) History of severe migraine within the past 1 year, diagnosed with thromboembolism, cerebrovascular disease, myocardial infarction, unstable angina, or coronary angioplasty 6) History of psychical disorder such as depression, anxiety disorders, or who taking medication of antidepressant, antianxiety drugs, antiseizure drug or sleep inducer etc. 7) Taking medication of Clonidine, anticoagulant drug or antiplatelet drug within the last 3 months 8) Taking medication of osteoporosis treatments (SERM; selective estrogen receptor modulator, bisphosphonate etc.) within the last 3 months 9) Taking medication of antihyperlipidemic agents or antidiabetic drugs within 3 months 10) Taking any other medication or dietary supplement that can affect menopausal symptom within the last month 11) Uncontrolled hypertension (systolic blood pressure=160 mmHg or diastolic blood pressure =160 mmHg) 12) HbA1c = 7.0 % 13) Major medical illness such as cardiovascular, neurologic, hepatic, musculoskeletal system, psychiatric, endocrine system, immune, renal, malignant tumor and pulmonary disease etc. 14) BI-RADS (breast imaging-reporting and data system) category = 3 15) Endometrial thickness more than 5 mm, or women who cannot measure endometrial thickness 16) BMI > 30 kg/m2 17) History of alcohol and drug abuse 18) History of disease that could interfere with the test products or impede their absorption such as gastrointestinal disease or gastrointestinal surgery 19) Allergic or hypersensitivity to drug and any of the ingredients in the test products (Isoflavones etc.) 20) Laboratory test by show the following results ? ALT, AST > 3-fold of normal range ? Serum creatinine > 2.0 mg/dl 21) Participation in other clinical trials within the last 3 months 22) Other circumstances that make the investigator expect an incomplete study participation of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score of KI;100 mm hot flashes VAS | — |
Secondary
| Measure | Time frame |
|---|---|
| Individual item score of modified KI;Mean duration of perceived hot flashes (min);Score of MRS;Osteocalcin, Type 1 collagen cross-linked telopeptide, Alkaline phosphatas;Cardiovascular risk factors (triglyceride, total cholesterol, HDL-C, LDL-C Endotheline-1, Apolipoprotein B, Apolipoprotein A1, Apoliproprotein B/A1 ratio, hs-CRP | — |
Countries
Korea, Republic of
Contacts
Public ContactMi-Ra Oh
Jeonbuk National University Hospital
Outcome results
None listed