Abstract

Objectives: This study was aimed to evaluate the hemodynamic feasibility using pulse parameters as a way to establish safe dose guidelines for ChungSimWon, and to provide a foundation for developing evidence-based guidelines for clinical use. Methods: Thirty nine volunteers were recruited to participate in a study examining the changes in pulse wave characteristics following the ingestion of ChungSimWon, over a period of 2 weeks, and pulse wave measurements were taken before and after the administration. Pulse wave parameters were measured in this study using a 3-dimensional radial pulse tonometry device(DMP-Lifeplus). In addition, questionnaire, blood pressure, temperature, and body composition were also measured as secondary measures. Results: Fifteen minutes after administration of ChungSimWon, the non-adverse event group(non-AE) exhibited a statistically significant increase in several power and pressure-related parameters and heart pumping performance, including h1, h3, h4, h5, SA(Systolic Area), PA(Pulse Area), PW(Pulse Width), SV(Stroke Volume), SVI(Stroke Volume Index), CO(Cardiac Output) and decrease in SVRI(Systemic Vascular Resistance Index), while the adverse event group(AE) showed a trend of increasing SV, SVI, CO, applied pressure and decreasing Systemic Vascular Resistance Index(SVRI). After 2 weeks of administration, non-adverse event group(non-AE) exhibited significant changes in HRV(Heart Rate Variability) LHratio(Low frequency-High frequency ratio), applied pressure and hemodynamic parameters while adverse event group(AE) showed significant changes in SV and SVRI. Notably, there are significant differences between AE group and non-AE group in wfb(front back of w) ratio, STD(standard deviation) pulse rate and hemodynamic parameter before medication. Conclusion: These findings suggest that pulse parameters may be a useful way to establish safe dosing guidelines for ChungSimWon. Further research is needed to confirm these results and to develop evidence-based guidelines for clinical use