None listed
Conditions
Interventions
Dietary Supplement : • Experimantal group: Take 2 tablet of red Platycodon grandiflorum root extract twice a day (red Platycodon grandiflorum root extract 1,500 mg/day)
• placebo group: In the same w
Sponsors
Gachon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult men and women aged =20 and <75 years 2. Subjects who agreed to participate in this study and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects with WBC <3,000 cells/µl or >10,000 cells/µl in the screening test 2. Subjects with BMI <18.5kg kg/m2 or >35 kg/m2 in the screening test 3. When it is not possible to perform the test conducted in the human study 4. Subjects who have the following symptoms/diseases or history - Subjects who have a medical history of gastrointestinal diseases (Crohn's disease, etc.) or operation (except appendectomy or herniotomy) - Uncontrolled diabetic patients (Fasting blood glucose = 180 mg/dL or in the case of medication changed or started anew within three months) - Uncontrolled hypertension patients (blood pressure = 160/100 mmHg or in the case of medication changed or started anew within three months) - Subjects with acute severe cardiovascular disease such as heart failure, myocardial infarction, and stroke - Subjects who have immune system disease or severe liver failure, renal failure or history - Subject who have thyroid gland or pituitary gland disease - Subjects who have systemic diseases such as malignant tumors, lung diseases, leukemia, collagenosis, multiple sclerosis, allergic skin diseases and other autoimmune diseases or history 5. Subject who show the following results in the screening test - AST, ALT > more than 2 times of the upper limit - Abnormal kidney function: Serum creatinine > 2.0 mg/dL 6. Subject who get a medical history of psychopharmacotherapy with in last 2 months before screening test 7. Subject who have experienced taking medicines, herbal medicines, and health functional foods that may affect their immune system within two weeks prior to the first intake of the experimental food (the health functional foods can be participated after a week's recess before the first intake of the clinical product) 8. When the use of prohibited drugs is expected during the study period 9. Subjects who have hypersensitivity history due to experimental product or ingredients 10. Subject who were participated in other clinical trials within the previous two months 11. In the case of continuous consumption of food or processed food from raw material for experimental food within 2 weeks 12. Pregnant or lactating women 13. Subject who do not perform adequate contraception in women of childbearing age (except woman who undergo sterilization operation) 14. Subject who deemed inappropriate to participate this clinical trial by research director due to other reasons including screening test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell activity | — |
Secondary
| Measure | Time frame |
|---|---|
| Interleukin-6, Interleukin-12;Interferon-? | — |
Countries
Korea, Republic of
Contacts
Public ContactAh Jin Jung
Gachon University
Outcome results
None listed