Efficacy and Safety Study of Ginseng Polysaccharide Extract

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Y-75; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 137-701
    • Seoul St. Mary's Hospital, The Catholic University of Korea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Y-75; volunteers receive 3 packages twice a day up to 14 weeks	Dietary supplement: Y-75; Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package; Other Names: Ginsan
Placebo Comparator: Placebo; volunteers receive 3 packages twice a day up to 14 weeks	Dietary supplement: Placebo; Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Health Biomed Inc.
• Investigators: Principal Investigator: Kyung-Soo Kim, MD, PhD, Seoul St. Mary's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: June 1, 2014
• First Submitted That Met QC Criteria: June 9, 2014
• First Posted (Estimate): June 11, 2014

Study Record Updates

• Last Update Posted (Estimate): June 11, 2014
• Last Update Submitted That Met QC Criteria: June 9, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: immunity; polysaccharide; natural killer cell; Panax ginseng CA; ginsan
• Other Study ID Numbers: Y-75