None listed
Conditions
Interventions
Dietary Supplement : Experimental: 350 mg/capsule/day as test group, Capsule will be administered orally once a day.
Control : 350 mg/capsule/day as placebo, Placebo capsule will be administered oral
Sponsors
Novarex
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 19 to 75 years inclusive at the time of screening. 2. Subject who have had acute upper respiratory tract infections or stomatitis more than twice within 12 months prior to the screening date. 3. Subject who decide to participate voluntarily after hearing a detailed explanation of this human application trial and fully understanding it, and have agreed in writing to comply with the precautions.
Exclusion criteria
Exclusion criteria: 1. Individuals who have continuously consumed probiotic-containing products or products containing killed microorganisms within 4 weeks prior to screening. 2. Individuals who have been vaccinated within 12 weeks prior to screening. 3. Individuals diagnosed with herpes zoster or allergic diseases or hypothyroidism within 12 weeks prior to screening. 4. Individuals with or with a history of malignant tumors, autoimmune diseases, or chronic inflammatory diseases. 5. Individuals who have taken antibiotics, antiviral drugs, immunosuppressants, steroids, antihistamines, or other medications that may affect immune function within 4 weeks prior to screening (Note: one-time transient use is acceptable). 6. Individuals who have continuously consumed health supplements or foods that may affect immune function. 7. Individuals who are continuously undergoing chemotherapy or radiation therapy. 8. Individuals with a history of treatment for alcohol addiction or substance abuse. 9. Individuals with a BMI of less than 18.5 kg/m2 or greater than 30 kg/m2 at the time of screening. 10. Individuals consuming excessive alcohol. 11. Individuals who smoke excessively. 12. Individuals with uncontrolled hypertension. 13. Individuals who are pregnant, breastfeeding, or planning to become pregnant during the clinical trial period. 14. Individuals who participated in another clinical trial within 2 months prior to the screening test. 15. Individuals deemed unsuitable for research participation by the principal investigator due to diagnostic medical examination results or other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nature Killer cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokines;CD markers of T cell, B cell, NK cell;inflammation factor | — |
Countries
Korea, Republic of
Contacts
Public ContactLee Kiheon
Seoul National University Bundang Hospital
Outcome results
None listed