KCT0007273招募中未知
A 8 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of CAEC on Immune Function
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 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
- 30(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Male or female subjects aged from 30 to 70 years old.
- •2) White blood cell (WBC) ranged from 4000 to 8000 cells/ul at visit 1.
- •3) Perceived stress scale (PSS) above 16 score.
- •4) Subjects who agreed to participate in this study and subjects who signed written informed consent voluntarily.
排除标准
- •1) Subjects who currently taking medications for an underlying disease, etc
- •2) Hypertension (systolic blood pressure above 140mmHg or diastolic blood pressure above 90mmHg, after 10 minutes of rest)
- •3) Diabetes (FBS(fasting blood sugar) level greater than 126 mg/dl or taking drugs due to diabetes)
- •4) TSH below 0.1µIU/mL or above 10µIU/mL
- •5) Vaccinated within 3 months before visit1 (influenza, COVID-19, herpes zoster, etc.)
- •6) Patients with diseases that can affect the immune response, such as adult asthma and rhinitis
- •7) Before visit 1, donate whole blood within 2 months or donate component blood within 4 weeks person who performed
- •8) AST(aspartate aminotransferase) or ALT(alanine aminotransferase) is more than 3 times the normal upper limit
- •9) Creatinine blood level is more than 1.5 times the normal upper limit
- •10) Subjects who have used steroids within 1 month based on visit 1
- •11) Subjects who have administered antibiotics, immunosuppressants, or proton-pump inhibitor within 1 month based on visit 1
- •12) Ingested dietary supplements and vitamin that can affect immune status within 2 weeks before screening
- •13) Complain of severe gastrointestinal symptoms such as heartburn, indigestion, etc.
- •14) Pregnant, breastfeeding or who have a pregnancy plan during this trial
- •15) Subjects who is participated in other trial within 8 weeks of the start of this trial, or plan to participate in other interventional clinical trials (including human trials) after the start of this study
- •16) sensitive or allergic to food for trial application
- •17) Body Mass Index (BMI) of 25 kg/m2 or more
- •18) Judged by the investigators to be inappropriate for the clinical trial
研究者
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