Journal of Korean Medicine Rehabilitation (한방재활의학과학회지)

The society of Korean Medicine Rehabilitation (한방재활의학과학회)
권호 표지
DOI QR코드

DOI QR Code

Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study

팔물탕연조엑스의 단회 경구 투여 안전성 평가에 관한 연구

  • Yeong-jin Jeong (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Su-Hak Kim (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Ji-Sung Lim (Department of Korean Medicine Rehabilitation, Jeonju Hospital of Oriental Medicine, Wonkwang University) ;
  • Young-Dal Kwon (Department of Korean Medicine Rehabilitation, Gwangju Medical Center, College of Korean Medicine, Wonkwang University)
  • 정영진 (원광대학교 광주한방병원 한방재활의학과) ;
  • 김수학 (원광대학교 광주한방병원 한방재활의학과) ;
  • 임지성 (원광대학교 전주한방병원 한방재활의학과) ;
  • 권영달 (원광대학교 광주한방병원 한방재활의학과)
  • Received : 2022.12.05
  • Accepted : 2022.12.19
  • Published : 2023.01.31
Download PDF
⟨ Previous Next ⟩

Abstract

Objectives This study is designed to evaluate the safety of palmul-tang soft extract in healthy male volunteers. Methods Twelve healthy male volunteers were recruited. And this study was conducted in a single center. As a result of the laboratory test, the safety was evaluated by collecting vital signs of volunteers. Twelve subjects were assigned by serial number according to the registration order. For safety evaluation, blood samples were collected and vital signs were checked four times throughout the test period, including screening, pre-administration, post-administration (after 48 hours) and post-administration (after 7 days). The difference in variables was summarized as the mean±standard deviation. The normality was performed using Kolmogorov-Smirnov and Shapiro-Wilk test. If normality is satisfied, a paired t-test is applied. Otherwise, the Wilcoxon sign rank test, which is a nonparametric method, is applied. The significance was p<0.05. The incidence of all side effects is expressed as a percentage. Results In the case of red blood cell, hemoglobin, and hematocrit values, the result of normality test of variables for the difference value before and after administration is significant level p<0.05. However, all laboratory test values before and after administration did not deviate from the normal range. Also the deviations in the normal range could not be seen as significance related to this clinical trial. And no side effects related to clinical trial drugs were observed. Conclusions The soft extract of palmul-tang was considered safe for healthy male volunteers.

Keywords

Acknowledgement

본 연구는 2022 원광대학교 교비지원에 의하여 연구되었음.

References

  1. Park YC, Lee SD. Evidence-based approach for herbal medicine-safety classification: human equivalent dose-based the margin of safety. Journal of Society of Preventive Korean Medicine. 2013;17(3):19-30.
  2. Ryu GC, Lee HW, Oh SJ, Park CJ. International competitiveness and tasks of Korean traditional medicine from the perspective of international comparison of curricula and research. Journal of Korean Institute for Health and Social Affairs. 2005;25(2):107-46.
  3. An SH, Jeong YJ, Kim JG, Shin HR, Kwon YD. Safety of bojungikgi-tang soft extract after single oral administration in healthy male volunteers, single center study. J Korean Med Rehabil. 2021;31(4):157-66. https://doi.org/10.18325/jkmr.2021.31.4.157
  4. Wang YZ. Lyuggwajunseung. Seoul:Lyulimsa. 1975:66-7.
  5. Ministry of Food and Drug Safety. Details on medication [Internet] 2018 [updated 2018 Sep 18; cited 2022 Oct 18]. Available from: URL: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetail?itemSeq=201803754.
  6. Korean Statistical Information Service. Information on the use of insurance herbal medicine [Internet] 2020 [up dated 2022 Jul 18; cited 2022 Oct 18]. Available from: URL: https://kosis.kr/statHtml/statHtml.do?orgId=354&tblId=DT_354004N_027&vw_cd=MT_ZTITLE&list_id=F_23_001&seqNo=&lang_mode=ko&language=kor&obj_var_id=&itm_id=&conn_path=MT_ZTITLE.
  7. Jung KY, Jang DR, Ha JH, Ma JY. A study on the acute toxicity of palmultang and fermented palmultang extract in ICR mice. Journal of Society of Preventive Korean Medicine. 2013;17(1):117-24.
  8. Ma JY, Yu YB, Ha HK, Huang DS, Shin HK. Subacute toxicity study on palmultang (bawu-tang) in SD rats. The Korea Journal of Herbology. 2007;22(4):59-64.
  9. Ma CJ, Lee NH, Yu YB, Ma JY, Ha HK, Shin HK. Analysis of studies on palmul-tang for establishment of evidence based medicine. The Journal of Herbal Formula Science. 2007;15(2):35-45.
  10. Lee KG, Huang DS, Yu YB, Ma JY, Ha HK, Shin HK. A study on compositions, dosages and usages of sagunjatang, samultang, palmultang, sipjeondaebotang in literature. Journal of Korean Medical Classics. 2006;19(4):219-25.
  11. Ha JY, Nam WY. Articles: experimental studies on anti-tumor and immunomodulatory effects of palmultang. Journal of Physiology & Pathology in Korean Medicine. 1995;9(2):295-315.
  12. Park HJ, Ko WS. The experimetal effects of palmultang on anti-cancer and immunologic function. Journal of Korean Medicine. 1998;19(1):327-38.
  13. Son JH, Jeong JH, Yoo DY. Effects of pal-mul-tang on cytokines production from immune cells during the late stage of pregnancy in BALB/c mice. The Journal of Oriental Obstetrics & Gynecology. 2000;13(1):342-75.
  14. Eun JS, Jeon H, Kim DK. Effect of palmultang on the phagocytosis of murine peritoneal macrophage. Korean Journal of Pharmacognosy. 1999;30(4):363-7.
  15. Kwon DB, Lim HH. Effects of palmul-tang (bawu-tang) and kamipalmul-tang (jiaweibawu-tang) on the recovery of fatigue in rats. J Korean Med Rehabil. 2002;12(1):89-100.
  16. Heo MK, Hong HW, Kam CW, Park DI. Experimental study on the anti-allergic effects of palmul-tang. Journal of Physiology & Pathology in Korean Medicine. 2003;17(4):1075-81.
  17. Oh YC, Jeong YH, Cho WK, Gu MJ, Ma JY. Inhibitory effects of palmultang on inflammatory mediator production related to suppression of NF-κB and MAPK pathways and induction of HO-1 expression in macrophages. International Journal of Molecular Sciences. 2014;15(5): 8443-57. https://doi.org/10.3390/ijms15058443
  18. Joo JM, Kim DC, Baek SH, Kim EH. The effect of palmultang (八物湯) on the ovarian functions and differential gene expression of caspase-3, MAPK and MPG in female mice. The Journal of Oriental Obstetrics & Gynecology. 2007;20(3):91-110.
  19. Park CH, Bae IT, Jeong HW. Effects of palmul-tang on the change of cerebral hemodynamics in rats. Journal of Physiology & Pathology in Korean Medicine. 2004; 18(4):1014-20.
  20. Park JK, Kwon SY, Jang EG, Woo HJ, Lee JJ, Kim YC. A case of gamipalmul-tang induced hepatitis. The Journal of Internal Korean Medicine. 2012;33(104):163-8.
  21. Lee SJ. The roll of complementary and alternative medicine in integrative medicine. Hanyang Medical Reviews. 2010;30(2):75-83. https://doi.org/10.7599/hmr.2010.30.2.75
  22. Park SK. An interpretation on abnormal finding of CBC. The Korean Journal of Medicine. 2010;78(5):531-9.
  23. The Korean Society for Laboratory Medicine. An interp retation of CBC test [Internet] 2012 [updated 2020 Jan 10; cited 2020 Jan 10]. Available from: URL: https://labtestsonline.kr/tests/cbc.