Efficacy and Safety Study of Ginseng Polysaccharide Extract

Seoul St. Mary's Hospital72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Y-75DIETARY_SUPPLEMENT

Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package

PlaceboDIETARY_SUPPLEMENT

Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, South Korea

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

Time frame: baseline, week 8, and week 14

Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12

Time frame: baseline, week 8, and week 14

Number of patients with laboratory abnormalities

Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis

Time frame: 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

Time frame: 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

Time frame: baseline, week 8, and week 14

Data from ClinicalTrials.gov

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