• 대한한의학방제학회지
• /
• 제24권4호
• /
• pp.301-309
• /
• 2016

Objective : The main objective of the study is to measure the satisfaction of patients with the Bojungikgi-tang Soft Extract, which is a herbal medicine in a new dosage form. Methods : Data were collected from 23 patients at Dongshin University Sunchun Korean Medicine Hospital through survey questionnaires. Results : A total of 23 patients were included in the study to know their satisfaction level towards the Bojungikgi-tang Soft Extract. It was found that most of the respondents were satisfied with the Bojungikgi-tang Soft Extract regarding its effectiveness, taste, convenience, price, and transportability in comparison to existing dosage forms. Conclusion : The study showed that most patients were more satisfied with the new drug dosage form than traditional forms and in needs of diversify of herbal medicine dosage forms.

• 한방재활의학과학회지
• /
• 제31권4호
• /
• pp.157-166
• /
• 2021

Objectives This study is designed to evaluate the safety of Bojungikgi-tang 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 difference between pre (before medication [0 hr]) and post-administration (after medication [48 hr]) variables was summarized as mean±standard deviation. The normality test was performed using the Kolmogorov-Smirnov test and Shapiro-Wilk test. When the normality is satisfied, the paired t-test is applied. Otherwise, the non-parametric method, Wilcoxon signed rank test is applied. The significance level was p<0.05. The incidence of all adverse effects are shown in percentage. Results In the case of red blood cell, hemoglobin, hematocrit, lymphocytes, neutrophils, protein, 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 Bojungikgi-tang soft extract were considered to be safe for healthy male volunteers.