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| Name | Class |
|---|---|
| Health Biomed Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Y-75 | Experimental | volunteers receive 3 packages twice a day up to 14 weeks |
|
| Placebo | Placebo Comparator | volunteers receive 3 packages twice a day up to 14 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Y-75 | Dietary Supplement | Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyung-Soo Kim, MD, PhD | Seoul St. Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul St. Mary's Hospital, The Catholic University of Korea | Seoul | 137-701 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25297058 | Derived | Cho YJ, Son HJ, Kim KS. A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75). J Transl Med. 2014 Oct 9;12:283. doi: 10.1186/s12967-014-0283-1. |
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| ID | Term |
|---|---|
| C111520 | ginsan |
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| Placebo | Dietary Supplement | Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment |
|
| 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 |