• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.17-31
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• 2024

Purpose: This study aims to develop preliminary items for measuring the perceived service quality of clinical trials among participants and to verify content validity. Methods: This study was designed as a methodological study. A conceptual framework was established based on Brady and Cronin's hierarchical model, and preliminary items were prepared through translation-back-translation, a review of existing instruments, and in-depth interviews with clinical trial participants and clinical research coordinators. The final items were completed through content validity testing by experts and a review of items by clinical trial participants for the prepared preliminary items. Results: Through this study, a set of 58 items across four domains (quality of interaction with researchers, the physical environment, performance procedures, and performance results) and 9 components (information·education·communication, trust, respect for participant preferences, securing facilities and space, accessibility, comfortability, informed consent, coordination of care, subjective understanding of clinical trials) on the service quality of clinical trials were completed. The scale content validity index of all preliminary items was 0.96, meeting the recommended standards. The individual-item content validity index also meets the recommended criteria for most items, excluding four items. Conclusion: This study holds significance in developing items to measure the quality of clinical trial execution from the perspective of participants. By verifying the reliability and validity of these items through subsequent research, it is expected that they can be utilized as a valuable instrument to devise strategies for improving the quality of clinical trials.

• 대한약학회:학술대회논문집
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• 대한약학회 2000년도 춘계총회 및 학술대회
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• pp.221.2-221.2
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• 2000

• 동의생리병리학회지
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• 제31권4호
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• pp.233-237
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• 2017

In this study, we report on the procedure of developing a guideline for clinical research protocol using moxibustion. Systematic review of the literature about moxibustion was conducted as a preliminary study to make basic content. Review and consulting by experts from each field was conducted to improve the quality. And we made checklist by arranging keypoint of this guideline. This guideline, Moxibustion Randomized Controlled Clinical Trial Guideline(MOXRATE), aims to be a guide for future researchers in planning clinical study using moxibustion as an intervention. MOXRATE also reports on an ethical issues.

• 대한한의학방제학회지
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• 제30권4호
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• pp.241-248
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• 2022

Objective : The purpose of this trial is to observe the preliminary effects of Salvia plebeia (SP) extract on quality of life in patients with solid cancer. Methods : This is a prospective, open-label, single-arm, and single-dose clinical trial. Twenty participants who have been diagnosed with solid cancer between the ages of 20 and 65 will be included. All participants will be administered SP granules for 12 weeks. Data will be collected at 4, 8, and 12 weeks after enrollment. The primary outcome is quality of life, using the Korean version of the Functional Assessment Cancer Therapy-General questionnaire. Secondary outcomes include tumor markers in blood tests for each cancer type, soluble programmed death-ligand 1, the percentage of natural killer cells among lymphocytes, ratio of T-helper and T-suppressor cells, ratio of total T, T-helper, T-suppressor, and B cells in lymphocytes, level of C-reactive protein, and tumor size via radiology examination. Safety will be assessed by clinical laboratory tests and monitoring of adverse events. Discussion : This study aims to observe the effects of an oral administration of SP preparations in patients with solid cancer on changes in quality of life and an improvement in immune function. It is expected to provide objective evidence of the effect and safety of SP for patients with solid cancer. Trial registration: KCT0007315 (Clinical Research Information Service)

• Natural Product Sciences
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• 제10권2호
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• pp.63-68
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• 2004

From the extracts of Crucianella maritima L. (Rubiaceae), five new anthraquinones namely; 1-hydroxy-2-methyl-6-methoxy anthraquinone, 6-methoxy-2-methyl quinizarin, 6-methyl-anthragallol-2,3-dimethyl ether, 6-methyl-anthragallol-2-methyl ether, and 1-hydroxy-2-carbomethoxyanthraquinone were isolated and identified. In addition, deacetyl asperulosidic acid 6'-glucoside sodium salt, a new iridoid diglucoside, along with twelve known anthraquinones, three flavonols, three sterols, and one triterpene were also isolated and identified for the first time from this plant. Their chemical structures were established by physical, chemical and spectroscopic data, including UV, MS, ID- and 2D-NMR analyses. The antimicrobial, cytotoxic activities and a preliminary clinical trial of the crude extracts and some isolates are also presented. Chemotaxonomical aspects are briefly discussed.

• 동의신경정신과학회지
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• 제26권1호
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• pp.49-61
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• 2015

Post traumatic stress disorder (PTSD) is an anxiety disorder that usually occurs after suffering from a psychological trauma that can not threatening events, which is one of the individual's subjective pain and their families and the larger society due to the chronic disease burden results. Treatment with a medication, as well as cognitive behavioral therapy (CBT), exposure therapy, prolonged exposure therapy (PE), eye-movement desensitizing, and reprocessing (EMDR) are preferentially performed, including psychotherapy. Korean medical psychotherapy consists of a wide range of manual therapy, but it does not have systematically screening limits. This study was developed by Korean medical psychotherapy program for PTSD, and it was carried out as a preliminary clinical trial for validity. The Korean medical psychotherapy program for PTSD consists of four stages as follows: building chapter of safety, flow and send, accept, and integration. Based on this preliminary clinical study of PTSD, seven patients were treated for 2 hours per week for 5 weeks. We report the meaningful results gained by observing the changes in IES-RK points, questionnaire on five-faceted mindfulness, quality of life, anxiety, depression, insomnia, hwabyung scale, HRV, and EEG, before and after the Korean medical psychotherapy program.

• 한방안이비인후피부과학회지
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• 제37권2호
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• pp.14-26
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• 2024

Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

• Journal of Acupuncture Research
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• 제28권3호
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• pp.55-71
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• 2011

Objectives : The purposes of this preliminary study was to examine the feasibility of recruiting women into a clinical trial designed to examine the effects of acupuncture in treating urinary incontinence (UI) in premenopausal women with delivery history and the feasibility of performing the study procedures. We also tried to determine if there was preliminary evidence to suggest that acupuncture may be effective in reducing UI and improving disease-specific quality of life. Methods : This study was a pragmatic randomized clinical trial. Subjects between the ages of 20 and 49 years were randomly assigned to a treatment(n=11) or control group(n=11) and analyzed. Both groups were supposed to do Kegel exercise at home during 4 weeks and acupuncture was applied to the treatment group twice a week(8 sessions) additionally. Subjects performed 1 hour pad test and completed a 3-day urination diary, international consultation on incontinence modular questionnaire(ICIQ), and incontinence - quality of life(I-QOL) at base line and 5 weeks. Results : Both group showed improvement in 1 hour pad test and the reducing amount of UI was significantly larger in treatment group(p=0.0182). The significant improvements in ICIQ and I-QOL were also observed in treatment group and sustained until the follow-up measurement at 16 weeks. Any adverse reaction related to acupuncture did not happen. Conclusions : It was feasible to recruit subjects and perform the study procedures. The positive results of this study support the requirement for additional research investigating the efficacy of acupuncture in the treatment of UI in women.

• 의료법학
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• 제20권2호
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• pp.173-206
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• 2019

본 연구는 최근 일본의 임상연구 관련 규율의 특색을 검토한 것이다. 첫째, 우리나라와 같이 일본에서도 그 동안 연구부정에 대해서는 엄벌주의를 취하여 왔지만, 최근 일본에서는 연구윤리정책을 제재가 아닌 교육연수에 의한 연구공정성 확보로 방향을 전환하였다는 점과 2018년 4월부터 시행된 임상연구법은 임상연구에 관한 자금제공 정보의 공표를 의무화하여 임상연구에 따른 자금제공의 투명성을 높인 점 및 의학계 연구의 윤리심사의 집약화 및 피험자를 집중시켜 증례나 우수한 연구자를 모집하여 임상연구·치험을 집약화한 점, 둘째, 그 동안 역학연구에 관한 윤리지침(이하, 「역학지침」이라 함)과 임상연구에 관한 윤리지침(이하, 「임상지침」이라 함)으로 이원화되어 있었던 윤리지침을 인간을 대상으로 하는 의학계 연구에 관한 윤리지침(이하, 「통합지침」이라 함)으로 통합 정비하여 임상연구와 역학연구에 필요한 윤리지침의 중복과 흠결을 보완했다는 점 이외에도 피험자보호를 위한 리스크 평가제도를 둔 점 이외에도 평가의 선결문제인 「침습」 개념을 명확히 했다는 점에서 긍정적인 평가를 받고 있다. 임상연구관련 국제규범상의 공통적인 내용인 「위험과 이익의 평가 문제」는 연구자의 연구가 적절히 고안되었는지를 검사하는 수단이다. 이는 연구윤리위원회가 피험자에게 가해질 위험이 정당화될 수 있는지 여부를 결정하는 방법이며, 장래의 피험자가 임상시험의 참여여부를 결정하는 중요한 기준이 되기도 한다. 그러므로 피험자의 리스크 평가의 선결문제인 「침습」 개념을 명확히 정의한 것은 의미 있는 것이다. 본 연구에서는 특히 최근 일본의 임상시험에서의 연구부정방지 대책에 대한 인식의 전환, 연구심사 및 피험자의 집약화를 통환 연구의 효율성 제고, 피험자 보호를 위한 리스크 평가의 전제가 되는 「침습」 개념의 명확화와 범위의 확장 등에 관한 논점을 중심으로 검토한 것이다.

• 대한한의학회지
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• 제32권4호
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• pp.128-138
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• 2011

Objective: This study aimed at providing preliminary data useful in reducing participant dropout and improving the quality of clinical trials, by analyzing the factors related to dropout. Methods: The data came from 15 acupuncture and/or moxibustion clinical trials (n=638; August 2005 to December 2009). Logistic regression analysis was used to reveal factors influencing participant dropout. Results: Gender, age, treatment method (intervention), treatment frequency, availability of follow-up, and presence of compensation treatment for the control group were factors influencing participant dropout. Conclusion: Subsequent studies of large-scale acupuncture and moxibustion clinical trials should address dropout factors that consider the character of each clinical trial, or general characters like participants' gender, age, occupation, and diverse diseases.