An 8-week, multi-center, randomized, double-blinded, placebo-controlled study of YHC-BE-2040 to evaluate efficacy and safety on immune functio

Not Applicable

Completed

• Conditions: Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

• Registration Number: KCT0008186
• Lead Sponsor: The Catholic University of Korea, St. Vincent's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-09-20
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Men and women over 40 and under 70
2. Those with a white blood cell count of 4.0×10^3 cells/µl or more and 8.0×10^3 cells/µl or less
3. A person who has given written consent to the human body application test consent form
4. Those who had symptoms of upper respiratory tract infection (cold, tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.) two or more times within one year before the start of the test

Exclusion Criteria

1. Subjects who have experienced adverse reactions such as hypersensitivity and allergy when taking health functional foods and medicines, including deer velvet extract
2. Subjects whose BMI is less than 18.5 kg/m^2 or greater than 30.0 kg/m^2
3. Subjects with immune-related diseases such as liver disease including active hepatitis, leukemia, inflammatory systemic diseases, infectious diseases, and autoimmune diseases
4. Subjects who have been diagnosed with dementia, brain tumor, or hydrocephalus, or have undergone or are receiving hormone replacement therapy within the last 4 weeks
5. Patients with stroke, heart disease (heart failure, arrhythmia, angina pectoris, myocardial infarction, history of pacemaker use), malignant tumor, narrow angle glaucoma, uncontrolled hypertension (SBP 140 mmHg or higher or DBP 90 mmHg or higher), or lung Patients with diseases or respiratory diseases
6. Subjects with severe renal dysfunction (eGFR <60 mL/min/1.73^2) or liver dysfunction (ALT, AST, ALP> upper limit of normal × 2.5)
7. If blood sugar control is difficult with hypoglycemic agents (despite taking hypoglycemic agents, fasting blood sugar 160mg/dl or higher) and subjects receiving insulin injections)
8. Persons with a platelet count of 100×10^3/µl or less
9. Those who have started taking oral steroids, hormones, etc. within the last 4 weeks, or have experienced taking drugs that affect the absorption, metabolism, and excretion of the test food
10. Those who have participated in other clinical trials or human application trials within the last 6 months
11. A person who has undergone a surgical operation within the last 6 months or has been receiving prohibited treatment within 4 weeks (health food for the purpose of strengthening immunity, herbal medicine, or drug that is likely to be abused)
12. Subjects who have undergone gastrointestinal dysfunction or surgery that may affect drug absorption, such as gastrectomy
13. Subjects with thyroid disease (thyroid or hormone abnormalities/abnormal thyroid levels)
14. Neuropsychiatric disorders (depression, schizophrenia), subjects who received psychological treatment
15. Subjects who have undergone surgery (including childbirth) within the last 6 months or are cancer patients
16. Drug addicts and those who have been vaccinated against influenza within the past 3 months, those who have taken immunosuppressants, non-steroidal anti-inflammatory drugs, steroid drugs, antihistamines, and antibiotics
17. Pregnant and lactating women and women of childbearing potential who disagree with the choice of an appropriate method of contraception (oral contraceptives, hormone implants, intrauterine devices, condoms, spermicides)
18. Subjects who have received a COVID-19 vaccine within the last 4 weeks, have taken immunosuppressants, or have taken other immune-improving functional foods
19. Whole blood donation within the last 2 months or component blood donation within 4 weeks
20. Subjects judged to be unable to comply with the requirements of the study or unsuitable for participation in this study, in the opinion of the study director (or the commissioned investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
K cell activity

Secondary Outcome Measures

Name	Time	Method
K cell count;Cytokines