Journal of Korean Medicine Rehabilitation (한방재활의학과학회지)

The society of Korean Medicine Rehabilitation (한방재활의학과학회)
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A Single Center Study on the Evaluation of Safety after Single Oral Administration of Peony Root Extract Tablets

작약엑스정 1회 경구 투여의 안전성 평가에 관한 연구

  • Su-Hak Kim (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University ) ;
  • Jeong-Su Park (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Tae-Seong Jeong (Department of Acupuncture & Moxibustion Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Seung-Hyun Oh (Department of Acupuncture & Moxibustion Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Young-Dal Kwon (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University)
  • 김수학 (원광대학교 광주한방병원 한방재활의학과) ;
  • 박정수 (원광대학교 광주한방병원 한방재활의학과) ;
  • 정태성 (원광대학교 광주한방병원 침구의학과) ;
  • 오승현 (원광대학교 광주한방병원 침구의학과) ;
  • 권영달 (원광대학교 광주한방병원 한방재활의학과)
  • Received : 2024.06.18
  • Accepted : 2024.07.08
  • Published : 2024.07.31
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Abstract

Objectives This study is designed to evaluated the safety of peony root extract tablet in healthy male volunteers. Methods 12 healthy male volunteers were recruited, and this study was conducted by a single center. The safety was evaluated by collecting laboratory test and vital signs of volunteers. As the registration process, 12 subjects were assigned by serial number. To evaluate safety, vital signs were checked and blood samples were collected 4 times during the screening period, pre & post-administration (after 8 hours) and post-administration (after 7 days). The difference in variables was summarized by the mean±standard deviation. The normality test was carried out using the Shapiro-Wilk test and Kolmogorov-Smirnov test. When normality is fulfilled, a paired t-test is applied and the significance level was p<0.05. And the incidence of all adverse effects and serious adverse effects are shown in percentage. Results In the case of vital sign, body temperature (BT) (℃) was 0.06±0.05 ℃ (p=0.008), and there was a statistically significant difference in before and after administration. However, clinical symptoms were not occurred and BT (℃) of all subjects before and after administration showed values within the normal reference value. There was no significant difference from the control group in all other vital signs and laboratory test data. And no side-effects associated to clinical trial drugs were followed. Conclusions The peony root extract tablet was considered to be safe for healthy male volunteers.

Keywords

Acknowledgement

This paper was supported by Wonkwang University in 2023.

References

  1. Leem J, Kim KI, Seo JH, Cheong MJ, Youn I. Perception, attitude, and demand for Korean medicine and Western medicine collaborative treatment of medical occupational groups in Korea: a scoping review. Integrative Medicine Research. 2021;10(1):100430. 
  2. Choi SJ, Kim DI, Yoon SH, Lim CY, Lee JM, Choe CM. Effectiveness and safety of Korean medicine for treating women with unexplained infertility: a multi-center observational study. Integrative Medicine Research. 2021;10(4):100751. 
  3. Cho JH, Oh DS, Hong SH, Ko H, Lee NH, Park SE, Han CW, Kim SM, Kim YC, Kim KS, Choi CW, Shin SM, Kim KT, Choi HS, Lee JH, Kim JY, Kang JY, Lee DS, Ahn YC, Son CG. A nationwide study of the incidence rate of herb-induced liver injury in Korea. Archives of Toxicology. 2017;91(12):4009-15.  https://doi.org/10.1007/s00204-017-2007-9
  4. Ju YS. Ungok herbology. Jeonju:Woosuk Press. 2013:1312-4. 
  5. Ministry of Food and Drug Safety. Details on medication (updated 2017 Jul 10) [Internet]. Ministry of Food and Drug Safety; 2017 [cited 2024 Apr 4]. Available from: URL: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=201705472aupdateTs2024-03-04%2015:17:11.0b. 
  6. Korean Statistical Information Service. Information on the use of insurance herbal medicine [Internet] 2020 [updated 2022 Jul 18; cited 2024 Apr 04]. Available from: URL: https://kosis.kr/statHtml/statHtml.do?orgId=354&tblId=DT_354004N_027&conn_path=I2 
  7. Kim CY, Lee SH, Hwang MS. Effects of Jakyakkamchobuja-tang on rheumatoid arthritis in rat model: systemic review and meta-analysis. J Korean Med Rehabil. 2023;33(3):79-96. 
  8. Lee YJ, Woo CH, Kim YJ, Kim HJ, An HD. The effect of Dangguijakyak-san on wound healing. J Korean Med Rehabil. 2023;33(3):47-65. 
  9. Huh TY, Ha DJ, Kim KM. The effect of Sayeok-san for insomnia: a systematic review and meta-analysis. The Journal of Internal Korean Medicine. 2021;42(4):547-62.  https://doi.org/10.22246/jikm.2021.42.4.547
  10. Kim JG, Im JS, An SH, Song YS. Anti-neuroinflammatory effects of Hwanggeumjakyak-tang on lipopolysaccharide-induced brain injury model in vivo and in vitro. J Korean Med Rehabil. 2021;31(4):1-11. 
  11. Jeon S, Lee EY, Nam SJ, Lim KM. Safety assessment of Paeonia lactiflora root extract for a cosmetic ingredient employing the threshold of toxicological concern (TTC) approach. Regulatory Toxicology and Pharmacology. 2024;149:105620. 
  12. Kim JE, Park JS, Kim DY, Yu YJ, Kim JE, Lim SC. A study on safety and drug interactions of herbal drugs that compose 100 herbals medication prescriptions. Yakhak Hoeji. 2021;65(2):72-86.  https://doi.org/10.17480/psk.2021.65.2.72
  13. Bak SM, Back SM, Kim DY, Jeung NY, Kim NY, Yang JY, Han KH, Kim YB, Min BS, Lee BS, P ark SH. Genotoxicity assessment of root extracts of Paeonia lactiflora Pall. Mutation Research Genetic Toxicology and Environmental Mutagenesis. 2023;886:503579. 
  14. Huang SJ, Wang R, Shi YH, Yang L, Wang ZY, Wang ZT. Primary safety evaluation of sulfated paeoniae radix alba. Acta Pharmaceutica Sinica. 2012;47(4):486-91. 
  15. Yazaki Y. Asakura internal medicine. 11th ed. Seoul: Woori Medical Books. 2020. 
  16. Park CW, Park SN. Development of standard and improvement of reliability in body temperature measurement. Journal of the Korean Society for Precision Engineering. 2007;24(9):32-6.