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@article{ART002580715},
author={Sung-Hu An and Park Kyung-Tae and Seung-ryong Yeom and Young Dal Kwon and Hea-Young Cho},
title={Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study},
journal={Journal of Korean Medicine Rehabilitation},
issn={1229-1854},
year={2020},
volume={30},
number={2},
pages={153-164},
doi={10.18325/jkmr.2020.30.2.153}

TY - JOUR
AU - Sung-Hu An
AU - Park Kyung-Tae
AU - Seung-ryong Yeom
AU - Young Dal Kwon
AU - Hea-Young Cho
TI - Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study
JO - Journal of Korean Medicine Rehabilitation
PY - 2020
VL - 30
IS - 2
PB - The Korean Academy Of Oriental Rehabilitation Medicine
SP - 153
EP - 164
SN - 1229-1854
AB - 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. (J Korean Med Rehabil 2020;30(2):153-164)
KW - Soshihotang soft extract;Herbal medicine;Drug compounding;Safety evaluation
DO - 10.18325/jkmr.2020.30.2.153
ER -

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. (2020). Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation, 30(2), 153-164.

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. 2020, "Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study", Journal of Korean Medicine Rehabilitation, vol.30, no.2 pp.153-164. Available from: doi:10.18325/jkmr.2020.30.2.153

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho "Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 30.2 pp.153-164 (2020) : 153.

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho. Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study. 2020; 30(2), 153-164. Available from: doi:10.18325/jkmr.2020.30.2.153

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. "Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 30, no.2 (2020) : 153-164.doi: 10.18325/jkmr.2020.30.2.153

Sung-Hu An; Park Kyung-Tae; Seung-ryong Yeom; Young Dal Kwon; Hea-Young Cho. Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation, 30(2), 153-164. doi: 10.18325/jkmr.2020.30.2.153

Sung-Hu An; Park Kyung-Tae; Seung-ryong Yeom; Young Dal Kwon; Hea-Young Cho. Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study. Journal of Korean Medicine Rehabilitation. 2020; 30(2) 153-164. doi: 10.18325/jkmr.2020.30.2.153

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon, Hea-Young Cho. Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study. 2020; 30(2), 153-164. Available from: doi:10.18325/jkmr.2020.30.2.153

Sung-Hu An, Park Kyung-Tae, Seung-ryong Yeom, Young Dal Kwon and Hea-Young Cho. "Safety of Soshihotang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study" Journal of Korean Medicine Rehabilitation 30, no.2 (2020) : 153-164.doi: 10.18325/jkmr.2020.30.2.153