A 8 week, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of CAEC on Immune Functio
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
- Registration Number
- KCT0007273
- Lead Sponsor
- AEKYUNG Industry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method K cell(natural killer cell) activity
- Secondary Outcome Measures
Name Time Method Cytokine;T Cell, B Cell, NK Cell Population;self evaluaion of improvement;frequency of common cold;Fatigue severity scale