None listed
Conditions
Interventions
Others(Fermented Oyster Extract) : Fermented oyster extract, 1,400mg/day, once a day, once a day 350mg 4 capsules,
Take it with water after dinner
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Women over the age of 45 2) The next confirmed menopause ? Those who have passed more than 1 year after the last menstruation as of the screening date ? Natural amenorrhea or screening for 6 months based on the biochemical criteria for menopause (FSH> 40 IU) Received bilateral oophorectomy = 6 weeks prior to visit.
Exclusion criteria
Exclusion criteria: 1) Those who received treatment such as Hormone replacement therapy, calcitonin, bisphosphonate within 6 months before screening test 2) Those who have been taking beta-adrenergic receptor inhibitors within 2 months prior to screening test 3) People with diabetes/hyperlipidemia that cannot be controlled within 2 months before screening test or People who take soy-containing health functional food 4) Within 2 months before the screening test, People who took herbal medicines (Ogapi, Hogol, Gokgisaeng, Sangsaeng) which can affect bone metabolism, treatments such as steroids (Dynol tablet, Edgol tablet, Won Alpha Tablet, Premina Tablet, Posteage, Preda Tablet). Those who have consumed healthy foods (soy isoflavone, black yeast culture powder, milk protein extract) which can affect bone metabolism, 5) People with liver disease or AST or ALT greater than twice the upper limit of normal 6) Patients with uncontrolled high blood pressure or heart disease such as angina pectoris-myocardial infarction 7) Patients with uncontrolled hyperthyroidism or hypothyroidism 8) Those who have taken other clinical trial drugs within 1 month 9) Those suffering from diseases affecting bone metabolism (cirrhosis/chronic renal failure/drug treatment Necessary anemia) 10) Patients with medically inappropriate administration of test food 11) Alcohol abuser 12) People with osteoporosis-related or other concomitant diseases that may affect the drug safety evaluation 13) Those who are being treated for psychiatric diseases 14) Others, those who are judged to be inappropriate by the judgment of the responsible researcher and the person in charge of testing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| osteocalcin | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Alkaline Phosphate;C-telopeptide of type-I collagen;N-telopeptide of type-I collagen;Estrogen;Growth Hormone;Deoxypyridinoline;DPD/OSC ratio | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Kim
Pusan National University Korean Medicine Hospital
Outcome results
None listed