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A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75).

Cho YJ, Son HJ, Kim KS - J Transl Med (2014)

Bottom Line: 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.Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.

View Article: PubMed Central - PubMed

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.

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.

Conclusion: Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.

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Related in: MedlinePlus

Flow-chart of the study.
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Fig1: Flow-chart of the study.

Mentions: A total of 72 randomized, healthy volunteers participated in this study and were considered for safety and intention-to-treat primary analyses. A total of 60 of the initial study subjects completed all procedures, with a dropout rate of 16.7 % comprising 12 withdrawals (7 with placebo and 5 with Y-75) (Figure 1). There was no notable difference between the two sets of statistical results, for which one was obtained from the intention-to-treat set and the other from the per-protocol set. Baseline characteristics of the participants are shown in Table 1. Characteristics were similar between the Y-75 and placebo groups. The study population had a mean age of 58.0 years and was predominantly female (97.2%).Figure 1


A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75).

Cho YJ, Son HJ, Kim KS - J Transl Med (2014)

Flow-chart of the study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4196019&req=5

Fig1: Flow-chart of the study.
Mentions: A total of 72 randomized, healthy volunteers participated in this study and were considered for safety and intention-to-treat primary analyses. A total of 60 of the initial study subjects completed all procedures, with a dropout rate of 16.7 % comprising 12 withdrawals (7 with placebo and 5 with Y-75) (Figure 1). There was no notable difference between the two sets of statistical results, for which one was obtained from the intention-to-treat set and the other from the per-protocol set. Baseline characteristics of the participants are shown in Table 1. Characteristics were similar between the Y-75 and placebo groups. The study population had a mean age of 58.0 years and was predominantly female (97.2%).Figure 1

Bottom Line: 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.Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.

View Article: PubMed Central - PubMed

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.

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.

Conclusion: Y-75 was shown to be a safe and potentially effective natural alternative for enhancing immune function.

Show MeSH
Related in: MedlinePlus