title: A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75).
abstract: BACKGROUND
  The Y-75 (Ginsan) acidic polysaccharide from Korean Panax ginseng has been shown to function as an immunomodulatory molecule. However, the efficacy of Y-75 has not been evaluated in clinical trial.
  
  
  METHODS
  We verified Y-75 (6 g/day) for safety and immune efficacy in 72 healthy volunteers aged 50-75 years using a randomized, placebo-controlled, parallel, double-blind study. The activities of natural killer (NK) cells and peripheral blood phagocytes, as well as serum levels of monocyte-derived mediators, were assessed before and after administration for 8 and 14 weeks. This trial is registered at ClinicalTrials.gov (NCT02161198).
  
  
  RESULTS
  Y-75 significantly enhanced NK cell cytotoxic activity by 35.2% and 40.2% from baseline after administration for 8 and 14 weeks, respectively. The phagocytic activity of peripheral blood cells was also significantly increased by 25.2% and 39.4% and serum level of TNF-α by 38.2% and 44.5% after treatment for 8 and 14 weeks, respectively. Differences in the efficacy of variables compared to the placebo group were also significant. Administration of Y-75 was well tolerated without treatment-related adverse events or alteration of complete blood cell count or blood chemistry over the entire study period.
  
  
  CONCLUSIONS
  Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.
authors.forename: Young-Jin
authors.initials: YJ
authors.lastname: Cho
authors.forename: Hyeog-Jin
authors.initials: HJ
authors.lastname: Son
authors.affiliation: Department of Family Medicine, Seoul St, Mary's Hospital, The Catholic University of Korea, Banpo-ro 222, Seocho-gu 137-701, Seoul, Republic of Korea. kskim@catholic.ac.kr.
authors.forename: Kyung-Soo
authors.initials: KS
authors.lastname: Kim
mesh_terms: D000368:Aged; D003602:Cytotoxicity, Immunologic / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007694:Killer Cells, Natural / Q000276:immunology; D008297:Male; D008875:Middle Aged; D009000:Monocytes / Q000166:cytology / Q000187:drug effects; D005894:Panax / Q000737:chemistry*; D010919:Placebos; D011134:Polysaccharides / Q000008:administration & dosage / Q000009:adverse effects* / Q000494:pharmacology*; D016896:Treatment Outcome
chemical_list: D010919:Placebos; D011134:Polysaccharides; C111520:ginsan