Journal of Ginseng Research

The Korean Society of Ginseng (고려인삼학회)
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Enhanced immunity effect of Korean Red Ginseng capsule: A randomized, double-blind and placebo-controlled clinical trial

  • Yi Yang (Scientific Research Center, Conbio Technology Group Co., Ltd.) ;
  • Jing Li (Laboratory Department, Tianjin Third Central Hospital) ;
  • Shengyuan Zhou (Preventive Treatment of Disease Center, The Second Affiliated Hospital of Tianjin University of TCM) ;
  • Daoyan Ni (Preventive Treatment of Disease Center, The Second Affiliated Hospital of Tianjin University of TCM) ;
  • Cailing Yang (Toxicology and Efficacy Evaluation Center, CAIQTEST (Beijing) Co., Ltd) ;
  • Xu Zhang (Scientific Research Center, Conbio Technology Group Co., Ltd.) ;
  • Jian Tan (Scientific Research Center, Conbio Technology Group Co., Ltd.) ;
  • Jingrui Yan (Scientific Research Center, Conbio Technology Group Co., Ltd.) ;
  • Na Wang (Scientific Research Center, Conbio Technology Group Co., Ltd.)
  • Received : 2023.08.13
  • Accepted : 2024.05.30
  • Published : 2024.09.01
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Abstract

Background: As a physiological function of body, immunity can maintain health by identifying itself and excluding others. With economic development and increasingly fierce social competition, the number of sub-healthy population is gradually increasing, and the most basic problem exposed is human hypoimmunity. Hypoimmunity can be manifested as often feeling tired, catching colds, mental depression, etc. In order to enhance immunity, eating healthy foods with the effect of enhancing immunity may become an effective choice. KRG has pharmacological effects of enhancing immunity. Because the screening and evaluation method of immune population are not unified, there are relatively few KRG immunity tests for sub-health population. It is of great significance to study the effect of KRG on people with hypoimmunity to improve sub-health status. Methods: This was a 180-day, randomized, double-blind, placebo-controlled clinical trial. According to the trial scheme design, 119 qualified subjects were included and randomly divided into the test group taking KRG and the placebo control group. Subjects need to check safety indicators (blood pressure and heart rate, blood routine, liver and kidney function, urine routine and stool routine) and efficacy indicators (main and secondary) inspection at baseline, efficacy indicators inspection during the mid-term of the test (90th days of administration), safety and efficacy indicators inspection after the test (180th days of administration). Results: After the test, the safety indicators of placebo control group and KRG test group were basically within the normal range, and there is no significant difference in fireness score between the two groups. Through follow-up interviews, it was found that the subjects in the test group and the control group had no adverse reactions and allergic reactions such as nausea, flatulence, diarrhea, and abdominal pain during the test period. Self-comparison of the test group, the results of the main efficacy indicators: (1) immune related health scores were significantly improved in the mid-term and after the test (P < 0.01), (2) CD3 and CD4/CD8 increased significantly after the test (P < 0.05), (3) IgG, IgA, IgM and WBC increased significantly in the mid-term and after the test (P < 0.01); the results of the secondary efficacy indicators: (1) TNF-α decreased significantly in the midterm (P < 0.05), IFN-γ decreased significantly in the mid-term (P < 0.01), (2) NK increased significantly in the mid-term and after the test (P < 0.05), (3) monocyte increased significantly in the mid-term and after the test (P < 0.01). Inter-group comparison of the test group and the control group, the results of the main efficacy indicators: (1) immune related health scores were higher than that of the control group in the mid-term and after the test (P < 0.01), (2) IgA of the test group was higher than that of the control group in the mid-term and after the test (P < 0.05); the results of the secondary efficacy indicators: (1) WBC of the test group was higher than that of the control group in the mid-term (P < 0.05); (2) monocytes of the test group were higher than that of the control group in the mid-term and after the test (P < 0.05), neutrophils of the test group were higher than that of the control group in the mid-term (P < 0.05). Conclusion: Taking KRG has no adverse effects on the health of the subjects. According to the standard of clinical trial scheme, the immune related health scores and IgA in the main efficacy indicators were positive, which shows that KRG is helpful in enhancing human immunity.

Keywords

Acknowledgement

The study was supported by a grant from the Korean Society of Ginseng.

References

  1. Yu JA, Lee JY, Kim TY, et al. Immune modulatory activities of arginyl-fructose (AF) and AF-enriched natural products in in-vitro and in-vivo animal models. Molecules 2021;26(8):2251. Published 2021 Apr 13.
  2. Qi XT, Zhao CY, Zhang JX, et al. Current evaluation situation and research strategies on enhanced immune function of health food containing Chinese materia medica. China J Chin Mater Med 2019;44(5):875-9.
  3. Luo C, Xu X, Wei X, et al. Natural medicines for the treatment of fatigue: bioactive components, pharmacology, and mechanisms. Pharmacol Res 2019;148:104409.
  4. Yang B, Qin QZ, Han LL, et al. Spa therapy (balneotherapy) relieves mental stress, sleep disorder, and general health problems in sub-healthy people. Int J Biometeorol 2018;62(2):261-72.
  5. Huo YH, Wang XL, Li JS, et al. Analysis of clinical manifestations of subheath status in a medical college of Guangdong Province. J South Med Univ 2007;4:448-9.
  6. Wang CZ, Anderson S, Du W, et al. Red ginseng and cancer treatment. Chin J Nat Med 2016;14(1):7-16.
  7. Chinese Pharmacopoeia Commission. Pharmacopoeia of the People's Republic of China. Beijing: China Medical Science Press; 2020. p. 160.
  8. Fan WX, Zhan ZL, Hou FJ, et al. Research progress on chemical constituents and pharmacological activities of Ginseng Radix et Rhizoma Rubra. Natural Product Research and Development 2021;33(1):137-49.
  9. Lee DJ, Sun YK, Wang XZ. Research review on pharmacological effects of Korean red ginseng. Journal of Basic Chinese Medicine 2023;29(4):625-30.
  10. Jeon H, Kim H, Bae C, et al. Korean red ginseng decreases 1-methyl-4-phenylpyridinium-induced mitophagy in SH-SY5Y cells. Journal of Integrative Medicine 2021;19(6):537-44.
  11. Alam MJ, Hossain MA, Bhilare KD, et al. Korean Red Ginseng modulates immune function by upregulating CD4+CD8+ T cells and NK cell activities on porcine. J Ginseng Res 2023;47(1):155-8.
  12. Zhang LL, Yang HY, Hao R, et al. Experience of Rhizoma curculigins, Herba epimedii, and Fructus lycii in improving the immune function and hypofunction of the elderly - three prescription by professor TONG Xiaolin. Jilin Journal of Chinese Medicine 2020;40(8):989-91.
  13. Fang Ye. A study of human feeding trials for boosting - immunity health food. Chinese General Practice 2014;17(5):542-5.
  14. Liu SJ, Huang ZS, Wu QG, et al. Diagnostic and quantitative criteria of syndrome of fire-heat. Chinese Journal of Modern Drug Application 2008;1:24-6.
  15. Brown Graham, Gosia Mikolajczak, Lyons Anthony, et al. Development and validation of PozQoL: a scale to assess quality of life of PLHIV. BMC Publ Health 2018;18(1):527.
  16. Hyun SH, Ahn HY, Kim HJ, et al. Immuno-enhancement effects of Korean Red Ginseng in healthy adults: a randomized, double-blind, placebo-controlled trial. J Ginseng Res 2021;45(1):191-8.
  17. Calder Philip C, Samantha Kew. The immune system: a target for functional foods? Br J Nutr 2002;88(2):S165-76.
  18. Chandra Ranjit Kumar. Impact of nutritional status and nutrient supplements on immune responses and incidence of infection in older individuals. Ageing Res Rev 2004;3(1):91-104.
  19. Kogut Michael H, Lee Annah, Elizabeth Santin. Microbiome and pathogen interaction with the immune system. Poultry Sci 2020;99(4):1906-13.
  20. Park Do Hwi, Han Byungcheol, Myoung-Sook Shin, et al. Enhanced intestinal immune response in mice after oral administration of Korea red ginseng-derived polysaccharide. Polymers 2020;12:2186.
  21. Murray Peter J. Immune regulation by monocytes. Semin Immunol 2017;35:12-8.
  22. Youn SH, Lee SM, Han CK, et al. Immune activity of polysaccharide fractions isolated from Korean red ginseng. Molecules 2020;25(16):3569.
  23. Khoshkam Z, Aftabi Y, Stenvinkel P, et al. Recovery scenario and immunity in COVID-19 disease: a new strategy to predict the potential of reinfection. J Adv Res 2021;31:49-60.
  24. Liu YY, Xia K, Liu SX, et al. Application of ginseng in COVID-19 based on the theory of "strengthing healthy Qi to eliminate patho-genic factors". J Emerg Tradit Chin Med 2023;32(5):829-33.
  25. Vulser Helene, Wiernik Emmanuel, Tartour Eric, et al. Smoking and the Association Between Depressive Symptoms and Absolute Neutrophil Count in the Investigations Preventives et Cliniques Cohort Study. Psychosom Med 2015;77(9):1039-49.
  26. The Medical Administration Department of the Ministry of Health of the People's Republic of China. National guide to clinical laboratory procedures. third ed. Southeast University Press; 2006. 11-1.