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International Journal of Frontiers in Medicine, 2025, 7(4); doi: 10.25236/IJFM.2025.070411.

Safety and Hypolipidemic Efficacy of Korean Red Ginseng Formula Tablet: A Randomized, Double-Blind and Placebo-Controlled Clinical Trial

Author(s)

Ping Zheng1, Yunting Hong2, Ming Zhang1, Huijuan Xiao1, Jing Li3, Yi Yang4

Corresponding Author:
Yi Yang
Affiliation(s)

1Nutrition Department, Tianjin Third Central Hospital, Tianjin, China

2Health Management Center, Tianjin Third Central Hospital, Tianjin, China

3Laboratory Department, Tianjin Third Central Hospital, Tianjin, China

4Scientific Research Center, Conbio Technology Group Co., Ltd., Tianjin, China

Abstract

This study evaluates the efficacy of Korean Red Ginseng Formula Tablet (KRGT) in reducing blood lipid levels through a human feeding trial. A previous study identified the KRGT, which improves blood lipids, by studying human hepatocellular carcinoma (HepG2) cells and animal models[1]. This randomized, double-blind, placebo-controlled trial lasted 60 days. In total, 113 participants who passed the health assessments were randomly assigned to either the trial or placebo group based on their blood lipid levels. The trial group received KRGT, whereas the control group received a placebo, with both groups taking four tablets twice daily. Changes in serum total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) levels were observed pre and post-intervention.The study observed no adverse changes in the mental state, sleep, diet, or bowel movements of the participants before and after the intervention. Blood tests, urinalysis, stool analysis, and blood biochemistry results were normal in both groups throughout the study period. After 60 days, the trial group exhibited significant reductions in TC, TG, and LDL-C levels compared with baseline (P<0.01). Moreover, compared with the placebo group, the trial group showed significant decreases in serum TC, TG (P<0.01), and LDL-C levels (P<0.05), with no significant difference in HDL-C levels (P>0.05). The total efficacy rate in the trial group was 25.5%, which was significantly higher than that in the placebo group (P<0.01). KRGT demonstrated clear lipid-regulating effects in humans and was well tolerated. This study confirmed the safety of KRGT and provided valuable insights into its mechanism of action in blood lipid regulation.There are numerous clinical and animal experiments proving the lipid-lowering effects of red ginseng, Crataegus Fructus and Cassiae Semen, but there has been no research on the lipid-lowering effects of this compound yet.

Keywords

Dyslipidemia, Korean Red Ginseng Formula Tablet, Randomized Controlled Trial

Cite This Paper

Ping Zheng, Yunting Hong, Ming Zhang, Huijuan Xiao, Jing Li, Yi Yang. Safety and Hypolipidemic Efficacy of Korean Red Ginseng Formula Tablet: A Randomized, Double-Blind and Placebo-Controlled Clinical Trial. International Journal of Frontiers in Medicine (2025), Vol. 7, Issue 4: 85-93. https://doi.org/10.25236/IJFM.2025.070411.

References

[1] M. Zheng, Y. Li, Z. Dong, Y. Zhang, Z. Xi, M. Yuan, H. Xu. (2023) Korean red ginseng formula attenuates non-alcoholic fatty liver disease in oleic acid-induced HepG2 cells and high-fat diet-induced rats. Heliyon, 9, e21846. 

[2] J. R. Zhu, R. L. Gao, S.P. Zhao, G.P. Lu, D. Zhao, J.J.Li. (2016) Guidelines for the prevention and treatment of adult blood lipid disorders in China (revised in 2016), Chin. J. Circ, 31, 937-953. 

[3] S.I. Chung, S.J. Nam, M. Xu, M.Y. Kang, S.C. Lee. (2016) Aged ginseng (Panax ginseng Meyer) reduces blood glucose levels and improves lipid metabolism in high fat diet-fed mice. Food Sci Biotechnol, 25, 267-273. 

[4] F. Shao, L.F. Gu, H.J. Chen, R.H. Liu, H.L. Huang, L.Y. Chen, M. Yang. (2017) Evaluation of Hypolipidemic and Antioxidant Effects in Phenolrich Fraction of Crataegus pinnatifida Fruit in Hyperlipidemia Rats and Identification of Chemical Composition by Ultra-performance Liquid Chromatography Coupled with Quadropole Time-of-flight Mass Spectrometry. Pharmacogn Mag, 13, 725-731. 

[5] F. Shao, L.F. Gu, H.J. Chen, R.H. Liu, H.L. Huang, G. Ren. (2016) Comparation of Hypolipidemic and Antioxidant Effects of Aqueous and Ethanol Extracts of Crataegus pinnatifida Fruit in High-Fat Emulsion-Induced Hyperlipidemia Rats. Pharmacogn Mag, 12, 64-69. 

[6] A. Diane, F. Borthwick, S. Wu, J. Lee, P.N. Brown, T.A. Dickinson, K.D. Croft, D.F. Vine, S.D. Proctor. (2016) Hypolipidemic and cardioprotective benefits of a novel fireberry hawthorn fruit extract in the JCR:LA-cp rodent model of dyslipidemia and cardiac dysfunction. Food Funct, 7, 3943-52. 

[7] S.H. Park, S. Chung, M.Y. Chung, H.K. Choi, J.T. Hwang, J.H. Park. (2022) Effects of panax ginseng on hyperglycemia, hypertension, and hyperlipidemia: A systematic review and meta-analysis. J. Ginseng Res, 46, 188–205. 

[8] H. Seo, B.D. Jeon, S. Ryu. (2015) Persimmon vinegar ripening with the mountain-cultivated ginseng ingestion reduces blood lipids and lowers inflammatory cytokines in obese adolescents. J. Exerc. Nutrition Biochem, 19, 1–10. 

[9] S.I. Chung, S.J. Nam, M. Xu, M.Y. Kang, S.C. Lee. (2016) Aged ginseng (panax ginseng Meyer) reduces blood glucose levels and improves lipid metabolism in high fat diet-fed mice. Food Sci. Biotechnol, 25, 267–273.

[10] Y. Zhang, L. Zhang, Y. Geng,Y. Geng. (2014) Hawthorn fruit attenuates atherosclerosis by improving the hypolipidemic and antioxidant activities in apolipoprotein E-deficient mice. J. Atheroscler. Thromb, 21, 119–128. 

[11] S. Rajendran, P.D. Deepalakshmi, K. Parasakthy, H. Devaraj, S.N. Devaraj. (1996) Effect of tinctur-e of Crataegus on the LDL-receptor activity of hepatic plasma membrane of rats fed an atheroge-nic diet. Atherosclerosis, 123, 235–241. 

[12] Z. Zhang, W.K.K. Ho, Y. Huang, A.E. James, L.W. Lam, Z.Y. Chen. (2002) Hawthorn fruit is hypolipidemic in rabbits fed a high cholesterol diet. J. Nutr, 132, 5–10. 

[13] Y. Luo, G. Chen, B. Li, B. Ji, Z. Xiao, G. Yi, F. Tian. (2009) Dietary intervention with AHP, a functional formula diet, improves both serum and hepatic lipids profile in dyslipidemia mice. J. Food Sci, 74 , H189–H195.

[14] J. Zhang, R. Liang, L. Wang, R. Yan, R. Hou, S. Gao, B. Yang. (2013) Effects of an aqueous extract of Crataegus pinnatifida Bge. var. major N.E.Br. fruit on experimental atherosclerosis in rats. J. Ethnopharmacol, 148, 563–569. 

[15] H. Xu, H.E. Xu, D. Ryan. (2009) A study of the comparative effects of hawthorn fruit compound and simvastatin on lowering blood lipid levels. Am. J. Chin. Med, 37, 903–908. 

[16] H.J. Hu, X.G. Luo, Q.Q. Dong, A. Mu, G.L. Shi, Q.T. Wang, X.Y. Chen, H. Zhou, T.C. Zhang, L.W. Pan. (2016) Ethanol extract of Zhongtian hawthorn lowers serum cholesterol in mice by inhibiting transcription of 3-hydroxy-3-methylglutaryl-CoA reductase via nuclear factor-kappa B signal pathway. Exp. Biol. Med. (Maywood), 241, 667–674. 

[17] S.Y. Zhuang, M.L. Wu, P.J. Wei, Z.P. Cao, P. Xiao, C.H. Li. (2016) Changes in plasma lipid levels and antioxidant activities in rats after supplementation of obtusifolin. Planta Med, 82, 539–543. 

[18] V.K. Awasthi, F. Mahdi, R. Chander, A.K. Khanna, J.K. Saxena, R. Singh, A.A. Mahdi, R.K. Singh. (2015) Hypolipidemic Activity of Cassia Tora Seeds in hyperlipidemic Rats. Indian J. Clin. Biochem, 30, 78–83. 

[19] T.F. Tzeng, H.J. Lu, S.S. Liou, C.J. Chang, I.M. Liu. (2013) Reduction of lipid accumulation in white adipose tissues by Cassia Tora (Leguminosae) seed extract is associated with AMPK activation. Food Chem, 136, 1086–1094. 

[20] J.Y. Lee, W.L. Liao, Y.H. Liu, C.L. Kuo, F.W. Lung, C.L. Hsieh. (2022) Oral administration of processed Cassia obtusifolia L. seed powder May reduce body weight and cholesterol in overweight patients with schizophrenia: A 36-week randomized, double-blind, controlled trial of high and low doses. J. Ethnopharmacol, 292, 115111.

[21] H.B. Li, K.Y. Fang, C.T. Lü, X.E. Li. (2007) Study on lipid-regulating function for the extracts and their prescriptions from Semen Cassiae and fructus crataegi. Zhong Yao Cai, 30, 573–575.

[22] B. Yang. (2020) Observe the Lipid-Lowering Effects of Hawthorn, Cassia Seed and Their Compatibility. Health Care Guidelines, 25, 260–261.

[23] M. Qiu, F. Xiao, T. Wang, S. Piao, W. Zhao, S. Shao, M. Yan, D. Zhao. (2020) Protective effect of Hedansanqi Tiaozhi Tang against non-alcoholic fatty liver disease in vitro and in vivo through activating Nrf2/HO-1 antioxidant signaling pathway. Phytomedicine, 67, 153140.

[24] Y. Gao, S.J. Zhang, J.J. Li, J.Q. Zhao, Q. Xiao, Y.L. Zhu, J. Zhang, W.X. Huang.(2020) Effect and mechanism of ginsenoside Rg1-regulating hepatic steatosis in HepG2 cells induced by free fatty acid. Biosci Biotechnol Biochem, 84, 2228-2240.

[25] S.J. Yoon, S.K. Kim, N.Y. Lee, Y.R. Choi, H.S. Kim, H. Gupta, G.S. Youn, H. Sung, M.J. Shin, K.T. Suk. (2021) Effect of Korean Red Ginseng on metabolic syndrome. J Ginseng Res, 45, 380-389.

[26] H.M. Hui, Y. Guan, J.J. Weng, J.P. Chen, M.L. Wu, C. Cui, F. Shao, Y.C. Zhu. (2020) Effects of Hawthorn Leaf Flavonoids on Regulating Lipid and Protecting Liver and the Expression of HMGCR and LDLR in Hyperlipidemia Mice. Chinese Journal of Modern Applied Pharmacy, 37, 2599-2604. 

[27] Y.Y. Gao, Q. Ou, X.D. Wei, L. Ma. (2011) The effect of total flavonoids from hawthorn leaves on PPARA, LXR, ABCA1 mRNA expression in AS model rats. Chinese Journal of Gerontology, 31, 2502-2504. 

[28] S.M. Liu, C. Sun, W.H. Xie. (2009) The effect of cassia seed extract on the expression of polyester genes in hyperlipidemic model mice. Chinese Traditional and Herbal Drugs, 40, 583-587.