• Korean Journal of Acupuncture
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• 제28권4호
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• pp.49-58
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• 2011

목적 : 본 연구는 감초의 염증에 대한 효과를 연구하였다. 감초의 에탄올 그리고 물로 추출한 두 가지의 약침액을 이용하여 쥐의 대식세포에서 유래한 RAW264.7 세포에 대한 염증 억제효과를 확인하였다. 방법 : Inducible nitric oxide synthase(iNOS), cyclooxygenase-2(COX-2)를 포함한 염증성 단백질의 발현과 extracellular signal-regulated kinase 1/2(ERK1/2) 그리고 phosphorylated ERK1/2 의 발현을 Western blot 으로 확인하였고, PGE2의 발현은 ELISA 로 확인하였다. 결과 : RAW264.7 세포에 감초의 물 혹은 에탄올 추출 약침액을 투여한 결과 투여된 농도에 따라 LPS로 유도된 NO의 생성이 억제되었으며 iNOS, COX-2, 그리고 인산화 ERK1/2 의 발현도 감소되었다. 결론 : 본 실험 결과, 적작약의 물 그리고 에탄올 추출 약침액에 대하여 항염증성 효과가 있음을 확인하였다.

• 한방안이비인후피부과학회지
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• 제20권3호
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• pp.138-146
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• 2007

Objective : To observe the trend in clinical study on atopic dermatitis(AD) over the last 3 years in order to develop a study methodology of AD in Oriental Medicine. Methods : Using the Pub med on line site; search terms: atopic dermatitis, field as title/abstract, limitation as published in the last 3 years, only items with links to full text, Humans, Clinical Trial, English. I observed the study contents of all this research and focused on the classification of treatments. I also observed of AD clinical trials registered on a clinical trial site(www.clinicaltrial.gov) on 23rd of June, 2007: study contents, localization and study designs. Results : Through the Pub Med site, I found 169 articles. Classified according to study subject, the studies related to treatment were 114(67.5%); physiology, pathology and prevention 12(7.1%); Diagnosis and Evaluation(7.1%); psychological aspects including quality of life 10(5.9%); diet and management 10(5.9%); epidemiology 7(4.1%); and others 7(4.1%). However, the treatment study of herb-medicine as intervention showed only 1 article. Futhermore, it wasn't based on Oriental Medicine philosophy. In the clinical trial site, there were 31 studies in which patients were recruited or planned for the future. The study on efficacy and safety of the medicine produced 14 trials, 5 comparative trials, 2 phototherapy, 2 diagnosis, 6 physiology and pathology, and 2 epidemiology. The trial institutions were concentrated in U.S.A. Conclusion : I suggest we'd better try to make a good clinical guideline and standardization of diagnosis and herb-medicine in order to develop a clinical study methodology of AD as soon as possible in the future. Even though it 's very hard to find the study methodology, we should aim to achieve positive results and show the evidence of the efficacy and safety of herb-medicine treatment for AD using Oriental Medicine.

• 동의신경정신과학회지
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• 제20권4호
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• pp.79-89
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• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• 한방안이비인후피부과학회지
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• 제26권2호
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• pp.78-87
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• 2013

Objectives : This work aimed to review clinical trial trend of Korean medicine's face rejuvenation and suggest future trial using embedded needle(Maesun) based on Evidence-based medicine's PICO Model. Methods : 46 papers were searched from Oasis and DBPia, then 8 papers were engaged in review of clinical trial trend. Based on PICO model, clinical trial's patient, intervention, and outcome measurement were suggested. Results : Evidence level of clinical trials is relatively low, because their study designs are almost case report or case series. No study have comparison groups. Outcome measurement is varied, however, 3D face scanner were used to measure before-after changes of face. Based on review, we suggested that necessity of intervention standardization, measuring of normal control group and 2D/3D combined outcome measurement of face. Conclusions : There are many demands for revealing efficacy and safety of Korean medicine's intervention, also for face rejuvenation using embedded needle. For meeting the level of demands, more rigorous works are needed.

• 대한한의학방제학회지
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• 제27권3호
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• pp.213-221
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• 2019

Objectives : The purpose of this study is to confirm the efficacy and safety of the treatment of gastritis with 'Hwangryunhaedok-tang'. Methods : Total 20 people, between 19 and 65 years old, will be recruited to participate in a comparative clinical trial. All subjects will take 2 capsules of Hwangryunhaedok-tang (Redoxin Cap.), 3 times a day, 30 minutes after meals, for 8 weeks. Outcomes will be measured at the baseline, 4th week, and 8th week. Primary outcomes is the improvement rates of gastritis symptoms, such as heartburn, nausea/vomiting, abdominal bloating, anorexia, heartburn, and trim. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2018011), and registered in Clinical Research information Service, one of WHO. Recruitment opened in April 2019 and is supposed to be completed by December 2019. Conclusions : This trial will provide clinical information to determine the efficacy and safety of treatment of gastritis with 'Hwangryunhaedok-tang'.

• 대한임상약리학회:학술대회논문집
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• 대한임상약리학회 2005년도 제14차 추계학술대회
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• pp.3-3
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• 2005

• Communications for Statistical Applications and Methods
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• 제19권6호
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• pp.877-884
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• 2012

Phase I trials determine the maximum tolerated dose(MTD) and the recommended dose(RD) for subsequent Phase II trials. In this paper, a MTD estimation method applied to a biased coin design is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the SM3 method and the NM method (Lee and Kim, 2012) using a Monte Carlo simulation study.

• 한국한의학연구원논문집
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• 제13권2호통권20호
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• pp.127-133
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• 2007

Objectives : This study were aimed to estimate the needs for clinical research educational program development focused on oriental medicine. Methods : Department Medical Research of Korea Institute of Oriental Medicine surveyed 204 certified subjects in total by using web-based questionnaires through e-mail from Jan. 17th to Jan. 31th, 2007. Reply from 62 on-line correspondents were collected and statistically analyzed. Results : The number of clinical trial involving oriental medicine continues to increase. According to the survey, many Issues were raised as problems such as difficulty of recruitment, lack of fund and lack of stepped program. Emphasized issues were clinical research methodologies, development of protocols and case report form (CRF), and Regulations including Institutional Review Boards (IRBs) in these three consecutive education training program. Conclusion : The results of this study may contribute to the development of an educational program for oriental medicine, a program that should be taken into consideration for developing practical items, such as, problem-based learnings which reflects participants' actual needs in their works. Also this report be used for future strategy plans and execution of training program for oriental medical clinical trial.

• 동의신경정신과학회지
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• 제29권1호
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• pp.35-46
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• 2018

Objectives: The aim of this trial is to evaluate the efficacy and safety of Yukwool-tang (Liuyu-tang) for the treatment of major depression in women by comparing the Yukwool-tang (Liuyu-tang)-treated group with the placebo-treated group and assessing the association of various biological factors related to depression through various outcome measures. Methods: This study is a single-center, randomized, double-blind, placebo-controlled, parallel-design clinical trial. The subjects to be selected are women between the ages of 19 and 65, and the registered subjects are to be randomly assigned to treatment with Yukwool-tang or the placebo control. The Yukwool-tang group will take 1 bottle of Yukwool-tang (30 mg) for 8 weeks, 3 times a day, before meals. The control group will take the placebo in the same way. The primary outcome to be examined will be the change between the total score after 8 weeks and the total score before the start of the study of the K-HDRS score. Secondary outcomes are assessed by the change in total score after 12 weeks of K-HDRS, K-HDRS remission rate, K-HDRS improvement rate, BDI-K, PITD, KSCL-95, ISI, STAI-K, EQ-5D, VAS, Emotional Stimulation Test, BDNF test, inflammatory cytokine and tumor necrosis factor test, intestinal microbiome test, dietary report and Beck's hopelessness scale. Results: This protocol has been approved by the IRB of Dunsan Korean Medicine Hospital of Daejeon University and is registered in the CRIS, and it is made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: Based on this protocol, when the trial is completed, its data can be used to access the validity and safety of Yukwool-tang for major depression in women, and it is also expected to be helpful in the study of the correlation between future treatment of Korean medicine for depression and related biological factors, and quality of life.

• 한국의료질향상학회지
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• 제7권2호
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• pp.168-179
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• 2000

Background : Economic evaluation of clinical pharmacokinetic consultation services for theophylline, which is being widely used recently, is considered in patients for both proper care and cost efficiency. Mathods : This is a cost-benefit analysis of clinical pharmacokinetic consultation service for theophylline. Trial groups were chosen from 2 general hospitals which was performing clinical pharmacokinetic consultation- services in 1998. Control group was chosen from another one general hospital. The analysis includes 25 patients (sample patients) for trial group and 17 patients for control group. Results : On the basis of incremental analysis, it is estimated that the total (direct and indirect) annual costs of the clinical, pharmacokinetic services of theophylline for the patients in the trial group was about \65 million, whereas total annual benefits from those services was estimated to be about \551 million. The net benefits incurred to the sample patients, thus calculated, was about \485 million per year. In the analysis, we assumed that indirect benefits accruing to those services were non-existent. If that amount was included, the estimated net benefits would be much greater than the calculated one. Conclusion : We found that clinical pharmacokinetic consultation services for theophylline could produce more marginal benefits than marginal costs by those services from the social point of view. More controlled prospective trial in the future would be helpful for affirmation of the results of this study.