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Efficacy and Safety Study of Ginseng Polysaccharide Extract

NCT02161198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-06-11

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Y-75

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

DIETARY_SUPPLEMENT

Placebo

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

Sponsors & Collaborators

  • Health Biomed Inc.

    collaborator INDUSTRY

  • Seoul St. Mary's Hospital

    lead OTHER

Principal Investigators

  • Kyung-Soo Kim, MD, PhD · Seoul St. Mary's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-04-30
Completion
2013-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161198 on ClinicalTrials.gov