• 동의생리병리학회지
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• 제20권6호
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• pp.1678-1727
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• 2006

This study was perfromed to develop the assessment guideline and endpoints for clinical trial with anticancer herbal medicine. The botanical products used to humans for long time may be applied to phase 3 clinical trial after submitting the evidences for safety and efficacy of them or completion of basic requirement of phase 1 and phase 2 for safety confirmation and dose determination. Syndrome improvement was chiefly evaluated by Zubrod and karnofsky(%) methods. We suggest the general clinical trial assessment with botanical products, by following assessment points, that is, tumor size for 50 points, survival fate for 10 points, major syndromes for 40 points. It is recommendable that the each symptom of Qi deficiency syndrome, blood deficiency syndrome and Qi stagnation syndrome was allocated by assessment points, Similarly, the each symptom was given the assessment points according to the severity of symptom, for example, slight for 3 points, moderate for 2 points and severe for 1 point in hepatocelluar carcinoma and lung cancer. Then, the efficacy of botanical products was evaluated by the difference between pre-treatment and post-treatment. Asking the neoplastic patients of questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. In addition, in case of lung cancer, 13 questions will be asked by the EORTC QLQ-C13 forms. As the assessment of endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hemopoietic damage and injury of liver and kidney, while the changes of syndromes of side effect can be evaluated by differentiation methods of Qi and blood and five viscera. However, it is still necessary to determine the ratio between scientific analytical method and Oriental differentiation method as well as confirm the Oriental assessment endpoints by clinical trial. In addition, we suggest the continuous development of assessment endpoints on other carcinomas except of hepatocelluar carcinoma and lung cancer in future.

• 사상체질의학회지
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• 제23권1호
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• pp.98-107
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• 2011

1. Objectives: In this research, job and stress of the staffs who is working on clinical trial of oriental medicine involved in the project of Korea Institute of Oriental Medicine (KIOM) was identified. And an efficient way to enhance the working ability of clinical trial of oriental medicine was developed by recognizing the relationship of job satisfaction, organizational commitment and job performance with their stress. 2. Methods: A survey was conducted on 18 staffs in 12 hospitals who is working in the project of The construction of constitutional information collecting system for the scientification of Sasang Constitution. The collected data was analyzed with computer software of SPSS 17.0 3. Results: The research results are as follows: 1. The staffs of clinical trial of oriental medicine responded that they want to receive the rewards for their work with a salary, and they felt that through clinical demonstration followed by SOP and front face photograph are the most difficult works in clinical trial of oriental medicine. 2. Permanent workers showed higher organizational commitment than temporary workers in the relationship of job satisfaction, organizational commitment and job performance with general characteristics(p=0.026). 3. In the relationship of job stress with general characteristics, the workers who are higher than college graduates had dissatisfaction in salary with the highest frequency(p=.004), and the workers whose monthly salary is higher than 2 millions won showed the lowest job stress(p=.021). 4. In the relationship of job satisfaction, organizational commitment and job performance with job stress, as job apprehension stress is increased, job performance is dramatically decreased(p=.027). And as improper salary stress is increased, job satisfaction and organizational commitment is dramatically decreased (p=.018, p=.050). 4. Conclusions: It was clearly evidenced that job satisfaction, organizational commitment and job performance is closely related with stress of the staffs who is working on clinical trial of oriental medicine. And it is highly recommended that the improvement of working condition and the decrease of job stress can enhance the working ability of them.

• Journal of Gastric Cancer
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• 제17권3호
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• pp.255-266
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• 2017

Purpose: Although Roux-en-Y (R-Y) reconstruction after distal gastrectomy has several advantages, such as prevention of bile reflux into the remnant stomach, it is rarely used because of the technical difficulty. This prospective randomized clinical trial aimed to show the efficacy of a novel method of R-Y reconstruction involving the use of 2 circular staplers by comparing this novel method to Billroth-I (B-I) reconstruction. Materials and Methods: A total of 118 patients were randomly allocated into the R-Y (59 patients) and B-I reconstruction (59 patients) groups. R-Y anastomosis was performed using two circular staplers and no hand sewing. The primary end-point of this clinical trial was the reflux of bile into the remnant stomach evaluated using endoscopic and histological findings at 6 months after surgery. Results: No significant differences in clinicopathological findings were observed between the 2 groups. Although anastomosis time was significantly longer for the patients of the R-Y group (P<0.001), no difference was detected between the 2 groups in terms of the total surgery duration (P=0.112). Endoscopic findings showed a significant reduction of bile reflux in the remnant stomach in the R-Y group (P<0.001), and the histological findings showed that reflux gastritis was more significant in the B-I group than in the R-Y group (P=0.026). Conclusions: The results of this randomized controlled clinical trial showed that compared with B-I reconstruction, R-Y reconstruction using circular staplers is a safe and feasible procedure. This clinical trial study was registered at www.ClinicalTrials.gov (registration No. NCT01142271).

• 동의신경정신과학회지
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• 제33권4호
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• pp.389-400
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• 2022

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

• Journal of Acupuncture Research
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• 제30권3호
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• pp.109-115
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• 2013

Objectives : This study was aimed to find the motivation and satisfaction of subjects who participated in acupuncture and moxibustion clinical trials and to suggest ways to improve clinical trial management. Methods : We conducted a survey and collected the data of 233 subjects of acupuncture and moxibustion clinical trials from 6 university hospitals. Results : For all 233 subjects, the mean of the total satisfaction score was 4.07 (perfect score 5.0), and the score was particularly high in aspects of the investigator and clinical research coordinator, but low in the site and sponsor aspects. There were no differences in the satisfaction degree with general characteristics. The satisfaction degree of the acupuncture and moxibustion clinical trials was strong positive correlated with participation benefits(r=0.595) and easy contact with the research team (r=0.500). Conclusions : Most subjects showed positive perception and interest in the clinical trials. Future studies should investigate how personal factors influence the satisfaction of subjects, should identify a specific classification criterion, and create a standardized protocol for the clinical trials.

• Genomics & Informatics
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• 제16권3호
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• pp.52-58
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• 2018

In this report, we present a case study of how pharmacogenomics and pharmacometabolomics can be useful to characterize safety and pharmacokinetic profiles in early phase new drug development clinical trials. During conducting a first-in-human trial for a new molecular entity, we were able to determine the mechanism of dichotomized variability in plasma drug concentrations, which appeared closely related to adverse drug reactions (ADRs) through integrated omics analysis. The pharmacogenomics screening was performed from whole blood samples using the Affymetrix DMET (Drug-Metabolizing Enzymes and Transporters) Plus microarray, and confirmation of genetic variants was performed using real-time polymerase chain reaction. Metabolomics profiling was performed from plasma samples using liquid chromatography coupled with quadrupole time-of-flight mass spectrometry. A GSTM1 null polymorphism was identified in pharmacogenomics test and the drug concentrations was higher in GSTM1 null subjects than GSTM1 functional subjects. The apparent drug clearance was 13-fold lower in GSTM1 null subjects than GSTM1 functional subjects (p < 0.001). By metabolomics analysis, we identified that the study drug was metabolized by cysteinylglycine conjugation in GSTM functional subjects but those not in GSTM1 null subjects. The incidence rate and the severity of ADRs were higher in the GSTM1 null subjects than the GSTM1 functional subjects. Through the integrated omics analysis, we could understand the mechanism of inter-individual variability in drug exposure and in adverse response. In conclusion, integrated multi-omics analysis can be useful for elucidating the various characteristics of new drug candidates in early phase clinical trials.

• 생물정신의학
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• 제19권4호
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• pp.159-163
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• 2012

An appropriate research design for hypotheses and purposes leads to a good quality of research results. In this review article, we summarized the types of research methods and described the characteristics of clinical trials. Research designs are categorized into observational studies and experimental ones, depending on data collecting methods. In an observational study, there are cross-sectional, cohort and case-control studies. Parallel groups design and crossover trial studies are representative designs in a randomized controlled trial study, a kind of experimental study. Clinical researchers should understand the characteristics of clinical research designs including advantages and disadvantages and choose the suitable design according to their study purposes and the nature of collected data or subjects.

• Clinical and Experimental Pediatrics
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• 제55권11호
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• pp.403-407
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• 2012

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

• Tuberculosis and Respiratory Diseases
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• 제75권2호
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• pp.47-51
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• 2013

Interstitial lung diseases are heterogeneous entities with diverse clinical presentations. Among them, idiopathic pulmonary fibrosis and connective tissue disease-associated interstitial lung disease are specific categories that pulmonologists are most likely to encounter in the clinical field. Despite the accumulated data from extensive clinical trial and observations, we continue to have many issues which need to be resolved in this field. In this update, we present the review of several articles regarding the clinical presentation, prognosis and treatment of patients with idiopathic pulmonary fibrosis or connective tissue disease-associated interstitial lung disease.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 1999년도 제8차 추계학술대회 및 정기총회
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• pp.34-34
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• 1999