None listed
Conditions
Interventions
Dietary Supplement : - Experimental group 50 people / placebo group 50 people
- 1 pouch per 1 time, 2 times a day
- Administration for 12 weeks
Sponsors
KolmarBNH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged from 45 to 70 years old. 2. Subjects who signed written informed consent voluntarily. 3. white blood cell (WBC) ranged from 4,000 to 6,000/µl. 4. Subjects suffered from upper respiratory tract infection or cold-related symptoms which have possibilities to cause upper respiratory tract infection more than two times in the past one year. (*Tonsillitis, pharyngitis, laryngitis, sinusitis, otitis media, rhinitis, etc.)
Exclusion criteria
Exclusion criteria: 1. History or presence of sensitivity or allergic to drugs or functional food including Angelica gigas Nakai, Cnidium officinale Makino, Paeonia lactiflora Pallas 2. Immune-related diseases, such as liver diseases including active hepatitis, leukemia, inflammatory systemic diseases, metabolic syndrome, infectious diseases, autoimmune diseases, etc. 3. Dementia, brain tumors, hydrocephalus, or who have conducted or are undergoing hormone replacement therapy within the last 4 weeks. 4. Stroke, heart disease (cardiac failure, arrhythmia, myocardial infarction, using implantable defibrillator), malignant tumor, angle close glaucoma, uncontrolled hypertension (SBP 140mmHg or higher or DBP 90mmHg or higher), lung disease, respiratory disease. 5. Serum creatinine> 2.0 mg/dl, AST (aspartate aminotransferase) or ALT (alanine aminotransferase) is more than 2.5 times the normal upper limit. 6. Insulin injection, FBS (fasting blood sugar) level is greater than 160 mg/dl even taking drugs to control blood sugar. 7. Any of the following below a) Platelet =100*103 b) WBC 4,000-10,000/ul 8. Taking oral steroids, hormones, etc. within the last 4 weeks or has taken drugs that affect the absorption, metabolism, and excretion of investigational product. 9. Took other investigational product or participated clinical trial medicines within the last 3 months 10. Surgical surgery within the last 6 months or receiving prohibited treatment within 4 weeks (medical food for enhanced immunity, herbal medicine, or medication for possible abuse). 11. Surgery that may affect the absorption of drugs, such as gastrointestinal dysfunction or gastrointestinal resection. 12. Thyroid disease (hypothyroid or hormonal abnormalities/hypothyroidism). 13. Neurological and mental disorders (depression, schizophrenia) and psychotherapy. 14. Surgery (including childbirth) or cancer patients within the last 6 months. 15. Drug addicts and subjects who have taken vaccine, immunosuppressants, nonsteroidal anti-inflammatory drugs, steroids, and antihistamines within the last 3 months. 16. Fertile woman who disagrees with the choice of pregnant women, breastfeeding women and appropriate contraceptive methods (oral contraceptives, hormone transplants, intrauterine instruments, condoms, and spermicide). 17. Immunosuppressive drugs or other immuno-improvement functional foods within the last 4 weeks. 18. Donated whole blood within the last 2 months or donated blood components within 4 weeks. 19. Taken antibiotics for more than 7 days. 20. Judged by the investigators to be inappropriate for the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NK cell avtivity | — |
Secondary
| Measure | Time frame |
|---|---|
| Cytokine (TNF-a, IFN-?, IL-2, IL-6, IL-12);NK cell, NK T cell count;CD4+/CD8+ ratio;lymphocyte count;POMS questionnaire scoring | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon Shin
Semyung University
Outcome results
None listed