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

소시호탕연조엑스의 단회 경구투여 후 안전성 평가에 대한 단일기관 연구

  • An, Sung-Hu (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Park, Kyungtae (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Yeom, Seung-Ryong (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Kwon, Young-Dal (Department of Korean Rehabilitation Medicine, Gwangju Medical Center, College of Korean Medicine, Wonkwang University) ;
  • Cho, Hea-Young (College of Pharmacy, CHA University)
  • 안성후 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 박경태 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 염승룡 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 권영달 (원광대학교 한의과대학 광주한방병원 한방재활의학과) ;
  • 조혜영 (차의과학대학교 약학과)
  • Received : 2020.03.16
  • Accepted : 2020.04.11
  • Published : 2020.04.30

Abstract

Objectives This study is designed to evaluate the safety of Soshihotang soft extract in healthy male volunteers. Methods 12 healthy male volunteers were recruited and this study was carried out by a single center. Laboratory test results, vital signs of the volunteers were collected to evaluate safety. According to registration order, the 12 subjects were allocated by serial number. To evaluate safety, blood samples were taken and vital signs were checked 4 times-screening, pre administration, post administration and follow up-during the whole trial. The incidence of all adverse effects are shown in percentage. The mean and standard deviation were used to to describe and summarize continuous data. To evalate the effectiveness of the intervention, data of blood tests was analyzed by Wilcoxon signed rank test or paired T-test (p<0.05). Results In the case of red blood cell, hemoglobin, hematocrit, neutrophils, protein, albumin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, γ-glutamyl transpeptidase values, the normality test result of the variable for the difference value before and after the dosing has a significance level <0.05. But most of values did not deviate from the normal range, and the deviation from the normal range could not be regarded as the significance associated with this clinical trial. And adverse event wasn't observed associated with the clinical trial drug. Conclusions Soshihotang soft extract were considered to be safe for healthy male volunteers.

Keywords

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