Efficacy and Safety Study of Ginseng Polysaccharide Extract

NCT02161198 | Completed Phase 2

• 1 other identifier: Y-75
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Panax ginseng CA; ginsan; polysaccharide; immunity; natural killer cell

Outcome Measures

Primary Outcomes (1)

• Mean percentage change in natural killer cell activity from a baseline level

  baseline (prior to the initial dose) , week 8, and week 14

Secondary Outcomes (5)

• 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

• Number of participants with serious and non-serious adverse events

  Up to 14 weeks

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

  baseline, week 8, and week 14

Study Arms (2)

Y-75

EXPERIMENTAL

volunteers receive 3 packages twice a day up to 14 weeks

Dietary Supplement: Y-75

Placebo

PLACEBO COMPARATOR

volunteers receive 3 packages twice a day up to 14 weeks

Dietary Supplement: Placebo

Interventions

Y-75 DIETARY_SUPPLEMENT

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

Also known as: Ginsan

Y-75

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Good general health

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• Health Biomed Inc.: collaborator

Study Sites (1)

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

Seoul, 137-701, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25297058 DERIVED

MeSH Terms

Interventions

ginsan

Study Officials

• Kyung-Soo Kim, MD, PhD

  Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 11, 2014
• Study Start: September 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 11, 2014

Record last verified: 2014-06

Locations

KR (1)