Clinical trial NCT02161198: Efficacy and Safety Study of Ginseng Polysaccharide Extract
Official title: A Single-center, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety After 14-week of Ginseng Polysaccharide Extract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Healthy
Keywords: Panax ginseng CA
ginsan
polysaccharide
immunity
natural killer cell
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Health Biomed Inc.
First posted: 2014-06-11
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean percentage change in natural killer cell activity from a baseline level
timeFrame: baseline (prior to the initial dose) , week 8, and week 14
Secondary outcomes:
measure: Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells
timeFrame: baseline, week 8, and week 14
measure: Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12
timeFrame: baseline, week 8, and week 14
measure: Number of patients with laboratory abnormalities
timeFrame: baseline, week 8, and week 14
measure: Number of participants with serious and non-serious adverse events
timeFrame: Up to 14 weeks
measure: Number of patients with abnormal findings in physical examination and vital signs
timeFrame: baseline, week 8, and week 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital, The Catholic University of Korea
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kyung-Soo Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.