KCT0006032尚未招募未知
A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract
Pusan National University Korean Medicine Hospital0 个研究点目标入组 120 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 45(Year) 至 0No Limit（—）
- 性别
- Female
入选标准
- •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.
排除标准
- •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
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