Skip to main content
OpenTrials
Completed

NCT Number: NCT02161198

Efficacy and Safety Study of Ginseng Polysaccharide Extract

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

Seoul, 137-701, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Y-75

Dietary Supplement

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

Other names: Ginsan

Placebo

Dietary Supplement

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

Primary outcomes

  1. 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

  1. Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells

    Time frame: baseline, week 8, and week 14

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

    Time frame: baseline, week 8, and week 14

  3. Number of patients with laboratory abnormalities

    Time frame: baseline, week 8, and week 14

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

  4. Number of participants with serious and non-serious adverse events

    Time frame: Up to 14 weeks

    Any change from the baseline status was defined as an adverse event

  5. Number of patients with abnormal findings in physical examination and vital signs

    Time frame: baseline, week 8, and week 14

    Physical examination includes body weight, ocular inspection, and heart and lung auscultation.

    Vital signs include blood pressure, heart rate, and body temperature

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Collaborators

  • Health Biomed Inc.

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2014
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.