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KMID : 0895820200300020153
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Journal of Oriental Rehabilitation Medicine
2020 Volume.30 No. 2 p.153 ~ p.164
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Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study
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An Sung-Hu
Park Kyung-Tae
Yeom Seung-Ryong
Kwon Young-Dal
Cho Hea-Young
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Abstract
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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.
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KEYWORD
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Soshihotang soft extract, Herbal medicine, Drug compounding, Safety evaluation
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