Efficacy and Safety Study of Ginseng Polysaccharide Extract

Seoul St. Mary's Hospital

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Dietary Supplement: Y-75; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02161198

Y-75

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Y-75

Experimental group

Description:

volunteers receive 3 packages twice a day up to 14 weeks

Treatment:

Dietary Supplement: Y-75

Placebo

Placebo Comparator group

Description:

volunteers receive 3 packages twice a day up to 14 weeks

Treatment:

Dietary Supplement: Placebo