KCT0006925招募中未知
A 4 week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of NAO on Immune function
Dynebio0 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
- 招募中
- 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 and female subjects aged between 20 years and 75 years
- •2) Those with a peripheral blood leukocyte count of 3X103 cells/µL or higher and 8X103 cells/µL or lower measured at Visit 1
- •3) Stress self-assessment scaled above strong
- •4) Those who have had upper respiratory tract infections twice or more within 1 year based on visit 1 {*tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc}
- •5) Those who agree to participate in this study before the study and fill out the Informed Consent Form
排除标准
- •1) Subjects who have past history or are currently in the treatment of significant clinical disease related to the 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 at 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 whose AST (GOT) or ALT (GPT) is higher than 3 times of normal upper limit in the blood
- •5) Subjects whose creatinine exceeds 1.5 times of normal upper limit in the blood
- •6) Subjects who got a vaccination within 3 months before screening.
- •7) Subjects who got a COVID-19 vaccination within 6 weeks before screening.
- •8) Subjects who have used steroids within 4 weeks before screening.
- •9) Subjects who have used immunosuppressants, gastric acid inhibitors, or statins within 2 weeks before screening.
- •10) Subjects who have used antibiotics within 2 weeks before screening.
- •11) Subjects who have consumed probiotics or lactobacillus products continuously (more than 4 times a week) within 2 weeks before screening.
- •12) Subjects who had intaken or is intaking functional foods that have the potential of affecting the immune system within 2 weeks s before the screening.
- •13) Subjects who have complained of severe gastrointestinal symptoms such as heartburn, indigestion.
- •14) Subjects who are planning a pregnancy, breastfeeding during this study.
- •15) Subjects who have participated in other interventional studies within 1 month before the screening, or who plan to participate in other interventional studies after the start of this study.
- •16) Subjects who are sensitive to foods or have food allergies.
- •17) Body Mass Index (BMI) of 30 kg/m2 or more
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