• 대한화장품학회:학술대회논문집
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• 대한화장품학회 1999년도 IFSCC . ASCS 학술대회 발표 논문
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• pp.1-5
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• 1999

The purpose of this study was to determine the effect of IPBC(3-lodo-2-propynylbutyl carbamate) on dandruff caused by the anthropophilic fungus Maiassezia furfur. The effects of IPBC on dandruff were examined by evaluating (a) the MIC value of IPBC using broth dilution method : (b) the remnant antimicrobial activity of IPBC containing shampoo on skin disc ; (c) the antidandruff efficacy of 1.0 % IPBC containing shampoo in double blind clinical trial. To investigate the remnant antimicrobial activity of IPBC against Maiassezia furfur, guinea pig-skin disc was washed with antidandruff shampoo and then the diameter of inhibition zone per disc was measured. For clinical trial, thirty healthy volunteers, aged 25-35, participated in 4 week study. At 0,2,4 weeks, examinations of scaling, itching on scalp were carried out. The MIC(Minimun Inhibition Concentration) values of IPBC range from 0.10 to 1.00$\mu$ g/ml and it seems that IPBC is more effective in the MIC values than zinc pyrithione, selenium disulphide, piroctone olamine and comparable to ketoconazole, climbazole. When the rimnant antimicrobial activity of IPBC shampoo on skin disc was determined, 0.5% IPBC shampoo and 2.0% Ketoconazole shampoo resulted in similar antimicrobial effect. In addition, 1.0%,2.0% IPBC shampoo was more effective than 2.0% ketoconazole shampoo. After two and four-weeks of 1.0% IPBC shampoo treatment, there was significant reduction of scaling, itching in test group compared to control group. On the basis of these results, it can be concluded that 1.0% IPBC is more effective than 2.0% Ketoconazole in reducing dandruff. It seems that strong capacity of drug binding to the stratum corneum plays a role in its antidandruff effect since adsorption of active ingredients on scalp is very important factor in reducing dandruff.

• Clinics in Shoulder and Elbow
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• 제25권2호
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• pp.129-139
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• 2022

Background: Several therapeutic methods have been proposed for frozen shoulder syndrome. These include suprascapular nerve block, a simple and cost-effective technique that eliminates the need for nonsteroidal anti-inflammatory drug therapy. Methods: This was a clinical trial that included patients with unilateral shoulder joint stiffness. Patients were divided into three groups: those treated with isolated physiotherapy for 12 weeks (PT group), those treated with a single dose intra-articular injection of corticosteroid together with physiotherapy (IACI group), and those treated with a suprascapular nerve block performed with a single indirect injection of 8-mL lidocaine HCL 1% and 2 mL (80 mg) methylprednisolone acetate together with physiotherapy (SSNB group). The variables assessed were age, sex, side of involvement, dominant limb, presence of diabetes, physical examination findings including erythema, swelling, and muscle wasting; palpation and movement findings; shoulder pain and disability index (SPADI) score; and the visual analog scale (VAS) score pre-intervention and at 2-, 4-, 6-, and 12-week post-intervention. Results: Ninety-seven patients were included in this survey (34 cases in the PT group, 32 cases in the IACI group, and 31 cases in the SSNB group). Mean age was 48.55±11.06 years. Fifty-seven cases were female (58.8%) and 40 were male (41.2%). Sixty-eight patients had a history of diabetes (70.1%). VAS and SPADI scores and range of mototion degrees dramatically improved in all cases (p<0.001). Results were best in the SSNB group (p<0.001), and the IACI group showed better results than the PT group (p<0.001). Conclusions: Suprascapular nerve block is an effective therapy with long-term pain relief and increased mobility of the shoulder joint in patients with adhesive capsulitis.

• 한방재활의학과학회지
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• 제33권1호
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• pp.77-85
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• 2023

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.

• 한방재활의학과학회지
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• 제29권4호
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• pp.101-108
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• 2019

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.

• The Korean Journal of Pain
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• 제31권1호
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• pp.27-38
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• 2018

Background: Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions. Methods: Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67. Results: Patients in this trial on average received $5.6{\pm}2.6$ procedures over a period of 2 years, with average relief over a period of 2 years of $82.8{\pm}29.6$ weeks with $19{\pm}18.77$ weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY. Conclusions: The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.

• Communications for Statistical Applications and Methods
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• 제25권3호
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• pp.321-328
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• 2018

In clinical trials with repeated measurements, the time-averaged difference (TAD) may provide a more powerful evaluation of treatment efficacy than the rate of changes over time when the treatment effect has rapid onset and repeated measurements continue across an extended period after a maximum effect is achieved (Overall and Doyle, Controlled Clinical Trials, 15, 100-123, 1994). The sample size formula has been investigated by many researchers for the evaluation of TAD in two treatment groups. For the evaluation of TAD in multi-arm trials, Zhang and Ahn (Computational Statistics & Data Analysis, 58, 283-291, 2013) and Lou et al. (Communications in Statistics-Theory and Methods, 46, 11204-11213, 2017b) developed the sample size formulas for continuous outcomes and count outcomes, respectively. In this paper, we derive a sample size formula to evaluate the TAD of the repeated binary outcomes in multi-arm trials using the generalized estimating equation approach. This proposed sample size formula accounts for various correlation structures and missing patterns (including a mixture of independent missing and monotone missing patterns) that are frequently encountered by practitioners in clinical trials. We conduct simulation studies to assess the performance of the proposed sample size formula under a wide range of design parameters. The results show that the empirical powers and the empirical Type I errors are close to nominal levels. We illustrate our proposed method using a clinical trial example.

• Journal of Periodontal and Implant Science
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• 제48권4호
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• pp.236-250
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• 2018

Purpose: Resorption of the alveolar bone is an unavoidable consequence of tooth extraction when appropriate alveolar ridge preservation (ARP) measures are not taken. The objective of this trial was to test the hypothesis that dimensional changes in the alveolar bone after tooth extraction would be reduced by inserting an equine collagen membrane and a collagen cone to fill and seal the alveolus (as ARP), in comparison to extraction with untreated alveoli. Methods: In this randomized clinical trial, 31 patients were directly treated with the collagen material after extraction of a tooth from the maxilla (the ARP group). Twenty-nine patients served as the control group. After extraction, no further treatment (i.e., no socket preservation measures) was performed in the control group. Changes in the alveolar process immediately after extraction and after an 8 (${\pm}1$)-week healing period were evaluated 3-dimensionally. Blinded analyses were performed after superimposing the data from the digitalized impressions and surfaces generated by cone-beam computed tomography. Results: Both the ARP and control groups showed a reduction of bone in the alveolar area after tooth extraction. However, significantly less bone resorption was detected in the clinically relevant buccal region in the ARP group. The median bone reduction was 1.18 mm in the ARP group and 5.06 mm in the control group (P=0.03). Conclusions: The proposed hypothesis that inserting a combination material comprising a collagen cone and membrane would lead to a difference in alveolar bone preservation can be accepted for the clinically relevant buccal distance. In this area, implantation of the collagen material led to significantly less alveolar bone resorption. German Clinical Trials Register at www.drks.de, DRKS00004769.

• 운동영양학회지
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• 제25권1호
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• pp.7-15
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• 2021

[Purpose] Sodium bicarbonate shows ergogenic potential in physical exercise and sports activities, although there is no strong evidence which performance markers show the greatest benefit from this supplement. This study evaluated the effects of sodium bicarbonate supplementation on time trial performance and time to exhaustion in athletes and sports practitioners. [Methods] A systematic review was conducted using three databases, including 17 clinical trials. Among these clinical trials, 11 were considered eligible for the meta-analysis according to the criteria for the assessment of methodological quality using the PEDro Scale. Time to exhaustion was assessed in six studies, while time trial performance was evaluated in five studies. [Results] A significant beneficial effect of supplementation on time to exhaustion was found in a random effects model (1.48; 95% confidence interval [CI], 0.49 to 2.48). There was no significant effect of supplementation on time trial performance in a fixed effects model (slope = -0.75; 95% CI, -2.04 to 0.55) relative to a placebo group. [Conclusion] Sodium bicarbonate has the potential to improve sports performance in general, especially in terms of time to exhaustion.

• 대한한의학회지
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• 제44권4호
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• pp.26-40
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• 2023

Objectives: This study was to evaluate the effectiveness and safety of Bojungikgi-tang for lung cancer patients with anorexia. Methods: This was a single-arm, open-label, and single-center trial, and suitable participants took Bojungikgi-tang (Buzhongyiqi-tang in Chinese, Hochuekki-to in Japanese) three times a day before or between meals for six weeks (42 days). After registration of clinical trials (visit 2), they visited the hospital every three weeks (visits 3 and 4) and measured or tested the effectiveness or safety evaluation variables to analyze the results. The primary outcome was the anorexia/cachexia subscale (A/CS) of functional assessment of anorexia/cachexia therapy (FAACT) score. Results: Seventeen lung cancer patients were included in the intention-to-treat (ITT) analysis. Lung cancer patients had higher A/CS of FAACT scores after six weeks of Bojungikgi-tang administration compared to that at the baseline. This was not significant four lung cancer (p=0.1668). In the secondary outcomes, the visual analog scale (VAS) score of anorexia decreased significantly (p=0.0009), and the CD4/CD8 ratio (p=0.0396) and CD4 levels (p=0.0345) significantly increased after six weeks of treatment. No serious adverse events were reported with Bojungikgi-tang in lung cancer patients. Conclusions: Bojungikgi-tang can be an effective and safe treatment for anorexia in lung cancer patients undergoing chemotherapy.

• 대한한의학회지
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• 제36권3호
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• pp.84-97
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• 2015

Objectives: The purpose of this study was to investigate and analyze the demands for educational programs on clinical trials of Korean medicine devices, and develop training programs based on the needs of Korean medicine. Methods: This research was conducted targeting 26 volunteer applicants who had participated in clinical trials of Korean medicine devices within the last five years (2010-2015). The survey was carried out between May 1, 2015 and May 26, 2015 via e-mail. After receiving questionnaire replies, the material was established. Using obtained data, frequency analyses were performed using SPSS 20.0 version. Results: 92% of the researchers who participated in the survey expected introduction of educational programs on clinical trials and anticipated that programs contain information that can meet the needs of each researcher. In addition, according to the analysis, introducing expert certification for clinical trials of Korean medicine devices is necessary, and offering related graduate courses are also needed. Conclusions: As a result of this study, researchers had difficulties during clinical trials of Korean medicine devices. If the educational programs were to be developed and institutional frameworks support them effectively, it would prove to be helpful to researchers in clinical trials.