|
KMID : 0895820230330010077
|
|
Journal of Oriental Rehabilitation Medicine
2023 Volume.33 No. 1 p.77 ~ p.85
|
|
|
Safety of Palmultang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study
|
|
Jeong Yeong-Jin
Kim Su-Hak
Lim Ji-Sung
Kwon Young-Dal
|
|
|
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.
|
|
|
KEYWORD
|
|
|
Herb-drug interactions, Herbal medicine, Drug compounding, Patient safety
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|