• Korean Journal of Acupuncture
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• 제28권3호
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• pp.177-186
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• 2011

Objectives : The aim of this study is to review clinical trials using Qigong exercise on patients with hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of Qigong exercise were performed in 21 electronic databases (5 international databases and 16 Korean databases). English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of 11 studies met the inclusion criteria. Five randomized controlled trials, Four non-randomized trials and two before-after studies were included. Seven studies used self-developed Qigong exercise. Two studies used Guolin Qigong exercise and two studies used Qigong exercise with an anti-hypertension drug. Of the nine randomized trials or non-randomized trials, four studies used an anti-hypertension drug control and three studies used waiting list controls. Compared to baseline, a change in blood pressure after the Qigong exercise treatment was significant in all studies. However, the results effect of blood pressure between Qigong exercise and controlled trials were not consistent. Conclusions : There are low-quality clinical trials of Qigong exercise for hypertension. To evaluate the effects of Qigong exercise, more rigorous trials are warranted.

• 대한한의학회지
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• 제41권1호
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• pp.107-116
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• 2020

Objectives: To overcome the limitations of randomized controlled trials, many other trials design is tested. The n-of-1 trial is a promising research method in the field of Korean medicine because of this methodology can examine the optimal treatment for each patient strictly. Therefore, we reviewed the status of N-of-1 studies on herbal medicine. Methods: A systematic literature review was conducted based on the pubmed database. The search term were 'N-of-1 Trial', 'Chinese Medicine', 'Herbal Medicine', 'Kampo'. There was no restriction in year. Results: Four clinical trials have been identified to demonstrate the effectiveness of herbal medicines for Kidney-yin-deficiency syndrome, bronchiectasis and gastric cancer. These studies suggest that the N-of-1 design is a study that encourages patient involvement, demonstrates the effectiveness of herbal medicines and helps reduce unnecessary medication. Conclusion: The N-of-1 clinical trial may be a rigorous methodology suitable for the clinical setting and may help the development of evidence-based Korean medicine. Attention is also needed in this research method in Korea.

• 대한한의학방제학회지
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• 제25권2호
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• pp.135-143
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• 2017

Objectives : This trial aimed to determine if Wasong (Orostachys japonicus) extract can enhance immune system and is safe enough to be approved as a health functional food. Methods : Total 62 people, aged 45 and older, will be recruited to participate in a randomized, double-blind, placebo-controlled clinical trial. This study will compare Wasong extract and placebo. Wasong group will take 1g of Wasong extract, once a day, for 8 weeks. Placebo group will take 1g of crystalline cellulose as placebo, once a day, for 8 weeks. Outcomes will be measured at the baseline, the end of 4th week, and 8th week. Primary outcomes are the ratio of NK cells/total lymphocytes and the ratio of T-helper cells/T-suppressor cells. Secondary outcomes are total white blood cell count, the ratio of neutrophils, lymphocytes, and monocytes in total leukocytes, the ratio of total T cells, T-helper cells, T-suppressor cells, and B cells to lymphocytes, the amount of blood IgM, IgG, IgA, and cytomegalovirus (CMV) IgG, and blood metabolite target &global analysis. Results : This trial was approved by institutional review board of Pusan National University Korean Medicine Hospital (registry number: 2016006), and registered in Clinical Research information Service, one of WHO International Clinical Trials Registry Platform (registry number: PRE20161006-002). Recruitment opened in February 2017 and is supposed to be completed by August 2017. The result is expected to be published by June 2018. Conclusion : This trial will provide clinical information to determine the efficacy and safety of Wasong in enhancing immune system of middle-aged and older people.

• Korean Journal of Acupuncture
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• 제29권4호
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• pp.581-597
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• 2012

Objectives : To explore the experiences of patients with chronic low back pain(CLBP) in a randomized controlled trial(RCT) of acupuncture. Methods : Five qualitative focus group interviews were conducted at three Korean Medicine Hospitals. Two to 4 participants from the same group(real or sham acupuncture) in the RCT of acupuncture for CLBP discussed their experiences and perceptions of the clinical trial and the acupuncture treatment. Transcribed data were read independently by researchers and analyzed to categorize information and identify themes. Results : A total of 14 participants were included. Most of them discovered positive aspects of being a study subject and a patient. They recognized the differences between experimental and real-world clinical settings such as formal procedures of treatment, and different acupuncture device. Participants also expressed the weaker sensation of acupuncture compared to the previous experience. Especially, they were well aware of the 'subjects' role themselves, thus they observed their changes of symptom closely. As subjects were generally satisfied with their treatment and they had a good feeling to acupuncture after the trial, they expressed their willingness to participate in the future clinical trial of acupuncture. Conclusions : Our finding suggests that the Korean patients' experience of participating in an RCT was generally positive. Their tendency to perform the 'subject' role might affect the trial's process or overall results.

• Korean Journal of Acupuncture
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• 제24권3호
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• 동의신경정신과학회지
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• 제22권4호
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• pp.31-39
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• 2011

Objectives : This study aimed to investigate frequently used herbal materials among herbal prescription for depression focusing on randomized controlled trial. Methods : Every article relevant to depression was initially obtained from China National Infrastructure(CNKI), Korean database and book hand-searching. Searching keywords were 'depression', 'herbal medicine' and 'randomized controllled trial(RCT)'. Results : Among comorbidity with depression, the most accompanied disease was that of circulatory system. Among sixty-five articles, depression with cerebral vascular disease was twenty-eight. Article about mood disorder was twenty-four. High frequently used herbal materials were Bupleuri Radix(41times), Curcumae Radix(34 times), Acori Graminei Rhizoma and Cnidii Rhizoma(24 times). Conclusions : According to this study, we could know select frequent-used herbal medicine. In a clinical treatment, herbal materials can be added herbal prescription related to depression. As these results, it can be helpful to develop new drugs.

• 대한한방소아과학회지
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• 제37권3호
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• Communications for Statistical Applications and Methods
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• 제18권2호
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• pp.179-187
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• 2011

제 1상 입상시험의 주된 목적은 신약의 최대허용용량(Maximum tolerated dose; MTD)의 추정이다. 본 논문에서는 실험으로 얻어진 Dose-toxicity data를 S자 모형에 적합 시켜 MTD를 추정하는 방법을 제안하였다. 멈춤 규칙(stopping rule)에 의해 MTD가 결정되는 방법과 미리 정해진 표본수에서 실험을 종료하고 MTD를 추정하는 기존의 추정방법을 본 논문에서 제안한 방법과 모의실험을 통하여 비교하였다.

• 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.

• 동의신경정신과학회지
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• 제23권4호
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• pp.37-48
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• 2012

Objectives : The purpose of this study is to investigate the frequently used herbal materials among herbal prescription for vascular dementia. Methods : Every article relevant to vascular dementia was initially obtained from a Korean database and PubMed. Keywords searched were 'vascular dementia', 'herbal medicine' and 'human'. Results : Clinical study, which vascular dementia were treated with herbal medicine, were 12. Among these 12 articles, 6 were case study, 1 was Controlled Clinical Trial and 5 were Ramdomized Controlled Trial (RCT). High frequently used herbal materials were Ginseng Radix (9 times), Cnidii Rhizoma (8 times), Glycyrrhizae Radix, Citri Pericarpium, Astragali Radix and Angelicae Gigantis Radix (6 times). Conclusions : We could know frequent-used herbal medicine for vascular dementia. To be aware of the frequently used herbal medicine for vascular dementia can be helpful in adding herbal materials to prescription in a clinical treatment and development of new drugs.