2.10. Study Design for Randomized, Double-Blind, Placebo-Controlled Clinical Trial 
hypothyroid, diabetes, kidney disease, osteoporosis
OVARIAN CANCER, UNCONTROLLED HYPERTENSION, HYPOTHYROID, PARATHYROID DISEASE, CUSHING SYNDROME, DISEASES, OSTEOPOROSIS
This study was a randomized, double-blind, placebo-controlled clinical trial for 24 weeks. The protocol was approved by the Kyung Hee University Hospital Institutional Review Board (IRB) (No: KMC IRB 2018-06-055). Women were eligible for the study if they were 45 or older, had more than a year since the last menstruation period, had both ovaries removed, were not taking menopause-related drugs or estrogen, and provided written informed consent for this trial. While patients were diagnosed with osteoporosis or under treatment, those who had diseases affecting osteoporosis (hypothyroid or parathyroid disease, Cushing syndrome, diabetes, kidney disease, ovarian cancer, and others) who had received hormone replacement therapy within the last three months, and who had undergone treatment for the spine were excluded. The study also excluded uncontrolled hypertension patients, body mass index (BMI) less than 18.5 kg/mBoth the test product and the control product are 500 mg per tablet (once a day). The test product components are the compound extract (containing Osteo-F freeze-dried powder 253 mg, 50.6%), and the other ingredients are dextrin (19.8%), microcrystalline cellulose (28.5%), HPMC (1.0%), and caramel pigments (0.1%). The control product consists of only the same subsidiary material (dextrin (40.0%), microcrystalline cellulose (58.9%), HPMC (1.0%), and caramel pigments (0.1%)) as the test product without Osteo-F.