Safety of <i>Bojungikgi-tang</i> Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study

An, Sung-Hu; Jeong, Yeongjin; Kim, Jong-gyu; Shin, Hye-ryung; Kwon, Young-Dal

doi:10.18325/jkmr.2021.31.4.157

Cited by 2 publications

(1 citation statement)

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“…탕제 연구 경우 모두 1일 1첩 분량의 처방을 2회 18,19,21) 내지 3회 20) 에 나누어 투여하였다(Table 1). [28][29][30] . 그러 나 방사선 조사나 항암제 투여를 통해 조혈계 손상 을 유발한 실험적 환경에서는 적혈구를 포함한 범혈 구 감소 억제 효과가 수차례 확인된 바 있다 [31][32][33] .…”

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Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Kim

Han

2023

J Korean Med

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Objectives: This study aimed to evaluate the efficacy and safety of Bojungikgi-tang (BJIG) and its modifications for patients with anemia.Methods: The subject of analysis of this study was a parallel design randomized controlled trial in which BJIG or its modifications was administered orally to patients who met the World Health Organization's anemia criteria and the efficacy and safety were prospectively measured. Electronic databases were searched to retrieve eligible literature published from 1 January 2000 to 12 February 2023. A meta-analysis was conducted, and the risk of bias (RoB) and level of evidence of the included studies was assessed using the Cochrane RoB 2 tool and GRADE method, respectively.Results: Five studies were included in the meta-analysis. When BJIG or its modifications was administered to anemia patients receiving conventional treatment, additional benefits compared to the non-administered group were found in terms of an increase in red blood cell count (mean difference (MD) 0.46 x 1012/L, 95% confidence interval (CI) 0.17 to 0.74), hemoglobin concentration (MD 9.28 g/L, 95% CI 6.06 to 12.51), hematocrit (MD 2.57%, 95% CI 1.76 to 3.38), total effective rate (odds ratio 5.29, 95% CI 2.05 to 13.68), and traditional Chinese medicine symptom scores (standardized MD -1.51, 95% CI -2.79 to -0.24).Conclusions: This study demonstrated the clinical potential of BJIG and its modifications to provide additional benefits to patients with anemia receiving conventional treatment.

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Section: ) 연구 대상자unclassified

Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Kim

Han

2023

J Korean Med

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

Jeong

Kim

Lim

et al. 2023

J Korean Med Rehabil

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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.

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Safety of Bojungikgi-tang Soft Extract after Single Oral Administration in Healthy Male Volunteers, Single Center Study

Cited by 2 publications

References 7 publications

Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Effects of Bojungikgi-tang and its modifications for Anemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

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

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