Healthy
Conditions
Keywords
Panax ginseng CA, ginsan, polysaccharide, immunity, natural killer cell
Brief summary
Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its function as an immunomodulatory molecule. The present study performed to evaluate the safety and beneficial effects of Y-75 on immune function in a group of healthy adults. The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear phagocytes, and serum levels of monocyte-derived mediators.
Interventions
DIETARY_SUPPLEMENTY-75
Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
DIETARY_SUPPLEMENTPlacebo
Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
Sponsors
Health Biomed Inc.
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Good general health
Exclusion criteria
* human immunodeficiency virus-1 infection * malignancy * active cardiovascular, renal, pulmonary, hepatic, neurological, psychiatric disease * recent (within 4 weeks) acute respiratory tract symptoms * immunosuppressive therapy including cytotoxic agents and corticosteroids * medication (within 4 weeks) deemed likely to interfere with the evaluation * history of allergic or other adverse reactions to ginseng products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage change in natural killer cell activity from a baseline level | baseline (prior to the initial dose) , week 8, and week 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells | baseline, week 8, and week 14 | — |
| Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12 | baseline, week 8, and week 14 | — |
| Number of patients with laboratory abnormalities | baseline, week 8, and week 14 | Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis |
| Number of participants with serious and non-serious adverse events | Up to 14 weeks | Any change from the baseline status was defined as an adverse event |
| Number of patients with abnormal findings in physical examination and vital signs | baseline, week 8, and week 14 | Physical examination includes body weight, ocular inspection, and heart and lung auscultation. Vital signs include blood pressure, heart rate, and body temperature |
Countries
South Korea
Outcome results
None listed