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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

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.

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