A 8 week, randomized, double-blind, Placebo-controlled clinical trial of CAEC(Canavalia gladiata Arctium lappa L.(root) Extract Complex) for the evaluation of efficacy and safety on immune function

AEKYUNG Industry0 个研究点目标入组 100 人开始时间: 待定最近更新: 2020年7月13日

试验速览

暂无简介。

•1) Male or female subjects aged from 25 to 75 years old.
•2) Screening white blood cell(WBC) ranged from 3000 to 8000 cells/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.

•1) history or presence of clinically significant acute or chronic cardiovascular, immune, respiratory, liver, biliary, renal, and urological system, nervous system, musculoskeletal disease, psychological, infectious, and hematologic / teratogenic diseases.(possible to participate judged by the investigators considering the condition of the subject)
•2) uncontrolled hypertension (above 160 / 100mmHg, after 10 minutes of rest)
•3) diabetes (FBS(fasting blood sugar) level greater than 126 mg/dl or taking drugs due to diabetes)
•4) vaccinated within 3 months before screening
•5) AST(aspartate aminotransferase) or ALT(alanine aminotransferase) is more than three times the normal upper limit
•6) Creatinine blood level is above normal level
•7) ingested dietary supplements that can affect immune status within 2 weeks before screening
•8) complain of severe gastrointestinal symptoms such as heartburn, indigestion, etc.
•9) Body Mass Index (BMI) of 25 kg/m2 or more
•10) pregnant, breastfeeding or who have a pregnancy plan during this trial
•11) plan to participate other trial during this trial
•12) participated in other trial within 8 weeks of the start of this trial
•13) judged by the investigators to be inappropriate for the clinical trial
•14) sensitive or allergic to food for trial application

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