Efficacy and Safety Study of Ginseng Polysaccharide Extract

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety After 14-week of Ginseng Polysaccharide Extract

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Y-75
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Y-75<br>volunteers receive 3 packages twice a day up to 14 weeks | Dietary Supplement: Y-75<br>* Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package<br>* Other names: Ginsan;|
| Placebo Comparator: Placebo<br>volunteers receive 3 packages twice a day up to 14 weeks | Dietary Supplement: Placebo<br>* Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis | baseline, week 8, and week 14 | 
| Number of participants with serious and non-serious adverse events | Any change from the baseline status was defined as an adverse event | Up to 14 weeks | 
| Number of patients with abnormal findings in physical examination and vital signs | Physical examination includes body weight, ocular inspection, and heart and lung auscultation. Vital signs include blood pressure, heart rate, and body temperature | baseline, week 8, and week 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panax ginseng CA, ginsan, polysaccharide, immunity, natural killer cell