KCT0002646已完成未知
A 8 week, randomized, double-blind, Placebo-controlled clinical trial of RB-F for the evaluation of efficacy and safety on immune function
STR Biotech0 个研究点目标入组 100 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
- 100
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
- 25(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •1) Male or female subjects aged from 25 to 75 years old.
- •2) Screening white blood cell(WBC) ranged from 3X103 to 8X103cells/ul.
- •3) Stress self assessment scaled above "strong"(4 scales: none, moderate, strong, intense)
- •4) Subjects suffered from upper respiratory track infection or cold-related symptoms which have possibilities to cause upper respiratory track infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.)
- •5) Subjects who agreed to participate in this study and subjects(or legal representative) who signed written informed consent voluntarily.
排除标准
- •1) Subjects who have past history or currently in the treatment of significant clinical disease related to acute or chronic cardiovascular system, immune system, respiratory system, liver biliary, kidney and urinary tract, nervous system, musculoskeletal disorders, psychic, infection and blood neoplastic.
- •(However, subjects are possible to participate in the study by the discretion of the study director)
- •2) Subjects who have uncontrolled high blood pressure. (Higher than 160/100mmHg, measured 10 minutes after stabilizing)
- •3) diabetes patients (fasting glucose level that is more than normal of this organization or had been taking or currently are taking a drug due to diabetes in the past
- •4) Subjects who got a vaccination within 3 months before screening.
- •5) Subjects whose AST (GOT) or ALT (GPT) exceeds 3 times of normal upper limit in the blood.
- •6) Subjects whose creatinine exceeds 3 times of normal upper limit in the blood
- •7) Subjects who had intaken or is intaking functional foods that have potential of affecting the immune system whitin 2 weeks s before screening.
- •8) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
- •9) Subjects who are planning a pregnancy, breastfeeding during this study.
- •10) Subjects who are planning to participate other studies during this study.
- •11) Subjects who were involved in other human applied studies within 8 weeks of this study begins.
- •12) Subjects who are deemed to be inappropriate to this human applied study.
- •13) Subjects who are sensitive to foods or have food allergies.
研究者
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