A Single-center, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety After 14-week of Ginseng Polysaccharide Extract
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 72
- Locations
- 2
- Primary Endpoint
- Mean percentage change in natural killer cell activity from a baseline level
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 50 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Mean percentage change in natural killer cell activity from a baseline level
Time Frame: baseline (prior to the initial dose) , week 8, and week 14
Secondary Outcomes
- 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)
- Number of participants with serious and non-serious adverse events(Up to 14 weeks)
- Number of patients with abnormal findings in physical examination and vital signs(baseline, week 8, and week 14)
Investigators
Kyung-Soo Kim
Professor
Seoul St. Mary's Hospital