Objectives The purpose of this study is to evaluate the safety of Gunghatang tablet in healthy male volunteers. Methods Single center pharmacokinetics study was carried out in healthy male volunteers. Through the laboratory test, vital sign and adverse event data, safety evaluation was conducted. Total 15 of 16 subjects who met the inclusion criteria were enrolled and three subjects were allocated to waiting group. 12 subjects were allocated by serial number according to registration order. Subjects took the maximum daily dose of the tablet on the second day of hospitalization. For the evaluation of safety, blood samples were collected and vital sign were checked 4 times (screening, before administration, after administration and follow up period) during the trial. All adverse events were recorded and summarized as frequency and percentage. All continuous data were summarized as mean and standard deviation. For comparison of variables between before administration and after administration, data were analyzed by paired T-test or Wilcoxon signed rank test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, there were no significant differences associated with the clinical trial drug between pre and post administration. And there was no adverse event associated with the clinical trial drug. Conclusions Gunghatang tablet were found to be safe for healthy male volunteers. (J
Introduction:Subacromial impingement syndrome (SIS) is one of the most common diseases inducing shoulder pain. Acupuncture is a source of pain relief that has been used for SIS; however, there is no clinical study about image-guided acupuncture for SIS. The aim of this study is to evaluate the effectiveness and safety of fluoroscopy-guided acupuncture in patients with SIS.Methods:This is the protocol for a randomized, patient-assessor blind, parallel clinical trial comparing fluoroscopy-guided acupuncture to acupuncture without fluoroscopy. There will be a 1-week run-in period before random allocation to 2 groups. The total duration of the clinical trial will be 3 weeks including 2 weeks for the follow-up period. A total of 57 participants will be enrolled for the clinical trial. Acupuncture will be conducted in 2 sessions for each group, once at baseline and once at the 1-week mark. The primary outcome will be 100 mm pain visual analogue scale. Secondary outcomes will include the Neer and Hawkins test, the Modified Constant Murley Score scale, the Shoulder Pain And Disability Index, the patient satisfaction degree, and the accuracy rate of acupuncture. For the evaluation of safety, adverse events will be monitored.Discussion:We designed the clinical trial using image-guided acupuncture. This will be the first trial to study the effectiveness of image-guided acupuncture for SIS compared with acupuncture using the proportional measurements.Trial registration:Clinical Research Information Service Registration Number is KCT0002751. Registered on March 23, 2018.
Objectives This study is a preliminary study for safe and accurate cervical Hyeopcheok acupuncture by comparing the depth of cervical Hyeopcheok acupoint with cervical spine rotation. Methods Researchers took ultrasonographic images of cervical Hyeopcheok acupoint during full rotation of cervical spine, 45 degree rotation and neutral condition in a prone position. 4 healthy volunteers were recruited. Results No significant difference in needling depth of cervical Hyeopcheok acupoint was observed. However, there were a differences in anatomical structures' shape such as muscles. Conclusions There are no significant difference in needling depth, but anatomical structures' shape were changed. This result mean that if patient rotate cervical spine during acupuncture treatment, it can occur complications. Thus, when acupuncture treatment on cervical Hyeopcheok acupoint, practioner should make subject's cervical spine alignment corrected and be careful not to change posture during the procedure.
Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.
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