KCT0000205已完成未知
A 4 week randomized, double-blind human trial to compare the effects and safety of powder of Aureobasidium pullulans cultured solution, mixture of Aureobasidium pullulans cultured solution and calcium lactate gluconate with placebo on metabolism of bone/joint in subjects
Glucan0 个研究点目标入组 90 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
- 90
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
- 40(Year) 至 70(Year)（—）
- 性别
- Female
入选标准
- •1.healthy adult female of 40-70 years old with no specific diseases
- •2.The osteogenesis marker of Osteocalcin value is within normal range or osteoclasis marker of deoxypyridinoline value is within normal range
- •3.Those who heard and completely understood the detailed description of this clinical test, and wish to participate voluntarily, and made a written consent to abide by the rules
- •4.Those who can be monitored during the human application test period
排除标准
- •1.Those who received hormone replacement therapy, calcitonin, or bisphosphonate treatment and such within 6 months of the screening test
- •2.Those who were taking beta-adrenaline acceptor suppressant within 2 months of the screening test
- •3.Those who are taking hyperlipidemia / endocrine disease treatments, hormone product, bean-containing health functional food, etc. within 2 months of the screening test
- •4.Those who are taking Vitamin D, K, and Ca supplement within 4 weeks of screening test
- •5.Those who are taking steroid-type drug or oriental medicine that may influence bone metabolism
- •6.Those who have had other clinical test medicine within 1 month
- •7.Cancer patients with breast cancer, ovary cancer, endometrium cancer, cervical cancer, bone cancer, etc.
- •8.Those with diseases influencing bone metabolism (liver, kidney diseases, blood diseases, etc.)
- •9.Those with important history or a current disease in terms of neurology/psychology
- •10.Expectant mother, lactating woman, fertile woman who do not agree to undertake an appropriate contraception method (hormone contraceptive: pills, intrauterine device: loop, block contraception: femidom, intravaginal spermicide), drug addicts
- •11.Others deemed inappropriate by the discretion of the researcher in charge or the test representative
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