• Journal of Acupuncture Research
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• v.28 no.5
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• pp.87-96
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• 2011

Objectives : The aim of this study is to review clinical trials using moxibustion on hypertension and to assess their methodology and results. Methods : Electronic literature searches for clinical trials (randomized trial, non-randomized trial, before-after study) of moxibustion were performed in nine electronic databases (four international databases and five Korean databases) and handsearch. English, Korean or Chinese articles were included. Laboratory or animal studies were excluded. Results : A total of twelve studies met the inclusion criteria. Seven randomized controlled trial, three non-randomized trials and two before-after studies were included. Seven studies used direct moxibustion(two are scarring one) and five used indirect one. Five of twelve studies used moxibustion treatment just one time, except for that most frequency was once daily or 2-3 times per week for 1-2 months. Of ten randomized or non-randomized studies, three used antihypertension drug control and another three used waiting list control. Compare to baseline, change of blood pressure after moxibustion treatment was significant in all studies. However, the results of effect in blood pressure between moxibustion and controlled were not consistent. Methodological quality of clinical trials included in this review was low and has risk of bias, especially in blinding of parcitipant. Conclusions : There are little high-quality clinical trials of moxibustion for hypertension. To evaluate the effect of moxibustion, more rigorous trials are warranted. Also, methodology of clinical trials have to be descripted in detail.

• Communications for Statistical Applications and Methods
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• v.18 no.2
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• pp.179-187
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• 2011

The purpose of a Phase I clinical trial is to estimate the maximum tolerated dose, MTD, of a new drug. In this paper, the MTD estimation method is suggested by curve fitting the dose-toxicity data to an S-shaped curve. The suggested MTD estimation method is compared with established MTD estimation procedures using a Monte Carlo simulation study.

• Journal of the Korean Data and Information Science Society
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• v.19 no.4
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• pp.1429-1440
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• 2008

In a meta-analysis combining the results from different clinical trials, it is important to consider the possible heterogeneity in outcomes between trials. Such variations can be regarded as random effects. Thus, random-effect models such as HGLMs (hierarchical generalized linear models) are very useful. In this paper, we propose a HGLM framework for analyzing the binominal response data which may have variations in the odds-ratios between clinical trials. We also present the prediction intervals for random effects which are in practice useful to investigate the heterogeneity of the trial effects. The proposed method is illustrated with a real-data set on 22 trials about respiratory tract infections. We further demonstrate that an appropriate HGLM can be confirmed via model-selection criteria.

• Neonatal Medicine
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• v.15 no.2
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• pp.113-118
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• 2008

Clinical trials in neonates of different gestational age, birth weight, postnatal age and general health status are needed to assure safe and optimal evidence-based-therapy to this special population. Pharmacodynamic maturation must be considered in grouping the neonates for clinical trials. Informed consent from the parents, protection of the neonates participating in the clinical trials, adherence to good clinical practice guidelines, and designation of short term and long term outcomes must be taken into consideration from the beginning of the trials. Collaboration between centers will be helpful in overcoming the problem with small patient size. Many of these challenges are surmountable and an well-designed clinical trial will improve the mortality and morbidity in these very small children.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.26 no.1
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• pp.104-117
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• 2013

Objective : The aim of this review is to development of clinical trial protocol for against cosmetics as a treatment of dry skin condition. Methods : We searched the literature from 2002 through April 2012 using 5 databases. We included randomized controlled trials(RCTs) in which human participants with dry skin condition as chief complaint were treated with cosmetics. The methodological quality of all RCTs was using the Jadad score. Results : Nine RCTs met the inclusion criteria. Cosmetic types included cream (7 trials), lotion (1 trial), oil (1 trial) and body wash (1 trial). The methodological quality of the trials was generally low (Jadad score: mean 1.78; range, 1 to 3). Conclusions : The evidence for cosmetics as an effective treatment for dry skin condition(xerosis) is currently scarce and of poor quality, and is therefore inconclusive. More rigorous studies are warranted.

• Herbal Formula Science
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• v.25 no.2
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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.

• Journal of Oriental Neuropsychiatry
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• v.20 no.2
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• pp.163-176
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• 2009

Objectives : To address most probable and suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on hwa-byung. Study Design : A systematic review of research studies of complementary and/or alternative medical(CAM) treatment of depression, and of domestic clinical trials of Traditional Korean Medicine, and of Chinese clinical trials of Traditional Chinese Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of depression intervening herbal medicine were searched through MEDLINE, Cochrane Library, and CNKI databases. Also, domestic RCTs intervening Traditional Korean Herbal Medicine were searched through Korean Traditional Knowledge Portal and Korean studies Information Service System(KISS). Studies were evaluated using Iadad scale and self-designed tool for this study. Results : Thirty four RCT studies( 10 from MEDLINE, 16 from CNKI, 8 domestic studies) of herbal medicine met inclusion criteria. Mean Jadad score of studies published in English was 2.8${\pm}$0.79, in Chinese 1.94${\pm}$0.77, and in Korean 2.75${\pm}$0.71. Twenty one percent of studies included pattern differentiation in their inclusion criteria. Twenty nine percent of studies used combined treatment of herbal and conventional medicine. Among studies on depression, 9% included Complementary Medical assessing tools. Conclusions : There is shortage of domestic clinical trial involving herbal medicine. In China, studies tend to focus on investigating effect of Combined treatment of herbal and conventional medicine on depression. Clinical trial(s) of hwa-byung should provide good internal validity by describing methodology for randomization, double-blinding, and attrition. Also, specific guideline for clinical trial, including Traditional Korean Medical aspects across inclusion criteria, and assessing tools is needed.

• Journal of Mycology and Infection
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• v.23 no.4
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• pp.91-98
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• 2018

Background: Malassezia, a lipophilic yeast, is a causative agent for dandruff and seborrheic dermatitis. Many biological agents have been studied for anti-Malassezia effect but further studies are needed for their clinical application. Objective: The study was conducted to evaluate the inhibitory effect of different natural essential oils and a fruit extract on Malassezia species in an in vitro study and a clinical trial. Methods: The antifungal effects of natural essential oils and a fruit extract on Malassezia species (M. furfur and M. sympodialis) were evaluated by measuring the minimum inhibitory concentration (MIC) and minimum fungicidal concentration (MFC) and using the disc diffusion method. Natural essential oils of citron seed, lavender, and rosemary and citrus junos fruit extract were used for the in vitro study. The clinical trial was conducted with a shampoo containing four ingredients. A total of 22 subjects used the shampoo every day for 4 weeks and were evaluated using clinical photography, trichoscopy, and sebumeter at baseline, 2 weeks, and 4 weeks after treatment. Results: Antifungal activity of agents was relatively lower in lavender and rosemary essential oils at MIC and MFC. Disc diffusion method revealed same results. In the clinical trial, the amount of sebum decreased statistically significantly and erythema, dandruff, and lesion extent also improved. Conclusion: The natural essential oils and fruit extract are effective for suppressing Malassezia activity, therefore these might be used as an alternative for treatment of dandruff and seborrheic dermatitis.

• Journal of Korean Medicine Rehabilitation
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• v.33 no.2
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• pp.49-55
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• 2023

Objectives The purpose of this study is to analyze randomized controlled trials about neuromuscular electrical stimulation for muscle wasting with cancer patient and evaluate it's motor functionality effect. Methods Studies will be searched from 7 online databases (PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure [CNKI], Korean studies Information Service System [KISS], Research Information Sharing Service [RISS], Oriental Medicine Advanced Searching Integrated System [OASIS]). Participants will be cancer patients with muscle loss, regardless of cause, gender, race or age, interventions will be neuromuscular electrical stimulation. Other treatments than interventions will be the control group and the main outcome will be reviewed by motor functionality effect. Results Randomized controlled trials about neuromuscular electrical stimulation for muscle wasting should be included in the study. Primary outcomes include motor functionality effect. Secondary outcomes evaluate adverse event. The data uses Review Manager Software 5.4. Conclusions The conclusion of this study will provide a basis for determining whether neuromuscular electrical stimulation treatment for muscle wasting with cancer patient treatment is an effective and safe treatment method in clinical practice.

• The Journal of Korean Medicine
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• v.31 no.1
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• pp.122-129
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• 2010

Objective: To investigate institutional review boards and approved clinical trials of Oriental medical hospitals in Korea Methods: We e-mailed 16 Oriental medical hospitals a survey consisting of questions that addressed two topics, institutional review boards and the clinical trials they approved. The first part included questions about whether each hospital had an institutional review board, that board's staffing and education, reviews, and expedited reviews. The clinical trials portion covered the number and types of approved clinical trials, treatment methods, whether an investigator or a sponsor initiated the trials, diseases, time frame, and clinical trial fee. Results: We received a response to our e-mail from 14 hospitals, all of which had an institutional review board. The average number of institutional review board members was 13.57. Of these Oriental medical hospitals, 70% and 49% said that they regularly educated their institutional review board staff and clinical trial, investigators, respectively. 79% of the hospitals claimed to conduct regular reviews, and 50% said that they did so monthly. The number of approved clinical trials increased sharply from 11 in 2005 to 102 in 2008. 68% of these clinical trials were randomized, and the most-used treatment methods were herbal medicine (35%) and acupuncture (29%). The most common target diseases were circulatory (19%), urinogenital (14%), and musculoskeletal (13%) disease. Conclusions: Despite the rapid increase in clinical research in oriental medical hospitals, many more efforts including raising IRB quality, varying research diseases and increasing clinical trials in the hospitals located in non-metropolitan area, should be made.