KCT0006718已完成未知
A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Osteo-F for bone health
BOIN BIO Convergence0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 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 o Limit（—）
- 性别
- Female
入选标准
- •1) Menopausal women over 45 years of age
- •2) A woman who do not take menopause-related drugs or estrogen
- •3) A person who agrees to participate in the study voluntarily and sign the informed consents
排除标准
- •1) A person who diagnosed with or undergoing treatment for osteoporosis
- •2) A person who suffering from diseases that affect bone metabolism (thyroid or parathyroid disease, Cushing's syndrome, diabetes, kidney disease, ovarian cancer, etc.)
- •3) A person who has received hormone replacement therapy (steroids, female hormones, thyroid hormones) within the last 3 months
- •4) A person who has continuously taken osteoporosis-related Western medicines, herbal medicines, or bone health-related health functional foods (calcium, vitamin D preparations, etc.) within the last 3 months
- •5) Patients with uncontrolled high blood pressure despite taking medication
- •6) Underweight or Obesity (BMI < 18.5 kg/m2 or BMI = 30.0 kg/m2)
- •7) A person who has a history of vertebral compression fractures or who have had spinal surgery
- •8) Rheumatoid disease, asthma, AIDS patients
- •9) Respiratory disease (chronic obstructive pulmonary disease), heart disease, chronic renal failure
- •10) A person who has gallbladder disease or gastrointestinal disease (gastrectomy, inflammatory bowel disease, malabsorption), gout, or porphyria
- •11) A persons with mental disorders such as schizophrenia, alcoholism, and drug addiction
- •12) Renal dysfunction (creatinine rise more than 1.5 times the upper limit of normal), liver dysfunction (increase of more than 2.5 times the upper limit of normal for AST and ALT), malignancy, and other diseases that the investigator considers inappropriate for this study
- •13) A person with allergy or hypersensitivity to ingredients of investigational product.
- •14) A person who have been diagnosed with or treated for cancer within the past 5 years
- •15) A person who have had surgery within the last 6 months
- •16) A person who has participated in other clinical studies within 1 month prior to the screening visit
研究者
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