• The Journal of KAIRB
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• v.6 no.1
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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.

• Proceedings of the PSK Conference
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• 2000.04a
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• pp.221.2-221.2
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• 2000

• Journal of Physiology & Pathology in Korean Medicine
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• v.31 no.4
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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.

• Herbal Formula Science
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• v.30 no.4
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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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• v.10 no.2
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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.

• Journal of Oriental Neuropsychiatry
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• v.26 no.1
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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.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.37 no.2
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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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• v.28 no.3
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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.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.173-206
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• 2019

This research examines the characteristic of regulation on Japanese clinical research in recent years. First, Japan has had a severe punishment policy on research misconduct like Korea, but, in recent days, Japan has changed the direction of research ethics policy from restriction to research publicness securement by educational training, in addition, Act of Clinical Research, effected April 2018, has recruited excellent researchers, and then integrated clinical research and medicine clinical trial through raising transparency of funding and integrating ethics screening by mandating announcement on funding information of clinical research. Second, Japan has integrated and organized ethics guideline from dual system that consists of ethics guideline on dynamic research(here after, referred to as 「dynamic guideline」) and ethics guideline on clinical research(here after, referred to as 「clinical guideline」) to ethics guideline on medical research aimed at human(here after, referred to as 「integrated guideline」), thus, it complements repetition and deficit of ethics guideline needed in clinical research and dynamic research, and it has risk evaluation system for protecting human subjects, and also it clarifies the concept of 「invasiveness」, a preliminary consideration of evaluation. 「Evaluation issue of risk and profit」, common contents of international regulation related clinical research, is the method to check whether the research is designed appropriately or not, this is the method for Institutional Review Board to decide whether the risk on human subjects could be justified, and also this is the important standard for future human subjects to participate in clinical trial. Therefore, it is meaningful to define 「invasiveness」 concept, a preliminary consideration of risk evaluation for human subjects. This research examines Japanese clinical trial focusing on change of awareness on prevention of research misconduct, efficiency improvement of research through research screening and integration of human subjects, and clarification and extension of range of 「invasiveness」 concept, a preliminary of risk evaluation to protect human subjects.

• The Journal of Korean Medicine
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• v.32 no.4
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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.