Efficacy and Safety Study of Ginseng Polysaccharide Extract

Phase 2

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Y-75; Dietary Supplement: Placebo

• Registration Number: NCT02161198
• Lead Sponsor: Seoul St. Mary's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2013-04
• Study Completion: 2013-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Study First Posted: 2014-06-11
• Last Update Posted: 2014-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Y-75	Y-75	volunteers receive 3 packages twice a day up to 14 weeks
Placebo	Placebo	volunteers receive 3 packages twice a day up to 14 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	baseline, week 8, and week 14	Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis
Number of participants with serious and non-serious adverse events	Up to 14 weeks	Any change from the baseline status was defined as an adverse event
Number of patients with abnormal findings in physical examination and vital signs	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

Trial Locations

Locations (1)

Seoul St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of