KCT0003664Completed未知
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
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- AEKYUNG Industry
- Enrollment
- 100
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional Study
Eligibility Criteria
- Ages
- 25(Year) to 75(Year) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Investigators
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