• Journal of Oriental Neuropsychiatry
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• v.33 no.4
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• pp.389-400
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• 2022

Objectives: Depression is a highly prevalent disease, and the market for antidepressant drugs continues to grow at a steady rate. Although current antidepressants are reported to be effective, because of their low remission rate and side effects, new antidepressants are needed. The use of Banhahubak-tang (BHT) to treat the symptoms of depression is supported by experimental evidence. The proposed study will evaluate the efficacy and safety of BHT in treating depression. Methods: A randomized, waitlist-controlled, parallel clinical trial will be conducted to assess the efficacy of BHT in depression. A total of 84 participants with depression will be randomized into the intervention group or waitlist-control group at a 1:1 ratio. Patients in the intervention group will be administered BHT three times a day for four weeks and followed up for four more weeks after therapy completion. Patients in the waitlist-control group will undergo the same intervention and follow-up after a four-week waiting period. The primary outcome is change in the Korean version of the Hamilton Depression Rating Scale (K-HDRS) scores for major depressive disorders after four weeks. The secondary outcomes include scores on the K-HDRS, Korean Symptom Check List 95 (KSCL-95), Insomnia Severity Index (ISI), State-Trait Anxiety Inventory-Korean version (STAI-K), State-Trait Anger Expression Inventory-Korean version (STAXI-K), and the Instrument on Pattern Identifications for Depression and EuroQol-5 Dimension (EQ-5D). Conclusions: This trial will provide high-quality clinical evidence of the efficacy and safety of BHT in the management of depression.

• Journal of Ginseng Research
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• v.38 no.4
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• pp.239-243
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• 2014

Background: To investigate the antidiabetic effects of hydrolyzed ginseng extract (HGE) for Korean participants in an 8-wk, randomized, double-blinded, placebo-controlled clinical trial. Methods: Impaired fasting glucose participants [fasting plasma glucose (FPG) ${\geq}5.6mM$ or < 6.9mM who had not been diagnosed with any disease and met the inclusion criteria were recruited for this study. The 23 participants were randomly divided into either the HGE (n = 12, 960 mg/d) or placebo (n = 11) group. Outcomes included measurements of efficacy (FPG, postprandial glucose, fasting plasma insulin, postprandial insulin, homeostatic model assessment-insulin resistance, and homeostatic model assessment-${\beta}$) and safety (adverse events, laboratory tests, electrocardiogram, and vital signs). Results: After 8 wk of HGE supplementation, FPG and postprandial glucose were significantly decreased in the HGE group compared to the placebo group. No clinically significant changes in any safety parameter were observed. Our study revealed that HGE is a potent antidiabetic agent that does not produce noticeable adverse effects. Conclusion: HGE supplementation may be effective for treating impaired fasting glucose individuals.

• The Journal of Advanced Prosthodontics
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• v.5 no.2
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• pp.204-208
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• 2013

PURPOSE. The purpose of this study was to evaluate the effectiveness of a promotion campaign for subject recruitment and selection, and reasons of withdrawal from a prospective clinical trial of mandibular two-implant supported overdenture. MATERIALS AND METHODS. The subjects of this study were participants in a randomized controlled clinical trial for investigating prognosis of implants and overdentures with attachments. Recruited subjects were classified by gender, age, and participation motives. Withdrawal rate of the participants before and after enrollment were evaluated. RESULTS. 177 patients were recruited and 51 patients were enrolled for the trial. Among them, 40 participants eventually took part in the trial. 116 subjects (65.5%) were recruited by advertisement and 61 (34.5%) were referred by patients of the hospital or local clinics. Regarding recruitment effectiveness, newspaper recruited the largest number of participants. With respect to referral patients, the proportion of our hospital patients was higher (37/61). Subjects in their 70s comprised the largest proportion (22/51). The male to female ratio was similar (25:26). Final withdrawal rate of all subjects were 74.0%. Among the reasons for withdrawal from enrollment (n=126) presence of remaining teeth and lack of motivation were the most common reasons. CONCLUSION. To facilitate recruitment of clinical trial subjects and improve enrollment rate, it is important to obtain a sufficient number of researchers, perform promotion activity with diverse strategies, cooperate with local dentists, increase the research funding, and alleviate subjects' fear against clinical trials by thorough consultation.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.30 no.4
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• pp.136-144
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• 2019

Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses. However, there have been a few robust evidences for effectiveness of early intervention until now. This review aims to identify the effectiveness of early intervention by investigating the randomized controlled trial (RCT) of early intervention for autism. There are some RCT studies using behavioral program. Although there are some significant findings, the outcome measurements and small sample size are the limitations. Further studies are needed.

• Journal of Acupuncture Research
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• v.26 no.5
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• pp.105-116
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• 2009

The use of acupuncutre has been increased worldwide, and large number of researches on acupuncture with improved quality has been conducted. Nevertheless, results of acupuncture treatment in those research tend to show mixed results, while many patients continuously seek acupuncture treatment as an adjuvant or alternatives for their health. Researchers and clinicians relevant to acupuncture are faced at this problematic discrepancy between the results of acupuncture in clinical trial including an randomized controlled trial and those of day-to-day clinical practice. The methodology of pragmatic clinical trial seems to be one of the promising research tools administering this problem especially in the area of complementary alternative medicine and traditional Korean medicine. In this study we first reviewed articles on the pragmatic clinical trial, summarized the essential concepts of 'explanatory' clinical trial 'pragmatic' clinical trial and then presented recent recommendations and arguments on this issue. We also analyzed and compared two similar pragmatic clinical trial protocols to show the readers the complexity of research designing. We hope more researchers in traditional Korean medicine will be interested in the methodology of pragmatic clinical trials and this study will serve to produce various high-quality clinical trials.

• Korean Journal of Acupuncture
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• v.26 no.1
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• pp.41-49
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• 2009

Objective : To make comprehensive picture of clinical trials using moxibustion and their results by today, then help a strategy for moxibustion-derived clinical studies in the future. Methods : Surveyed literatures containing randomized controled clinical trial (RCT) from PubMed and Korean journals. Analysis was performed according to distribution mainly by study subject, target diseases, study design, and its efficacy. Results : Fifty two literatures were selected according to inclusion criteria of randomized controled clinical study. Moxibustion-derived RCT have been rapidly increased from 2003 since the first was published in China in 1992. The main subjects of RCT are associated with immunity, cancer, arthritis, chronic colitis and urogenital disorders, which are connected to cold-elated pathogenesis. The average number of subjects was 94, and direct-moxibustion was mainly applied. The control groups were set up by giving conventional therapy, herbal medicine, acupuncture or only observation. The most of RCTs showed positive results. Conclusions : This study would be helpful for designing or conducting RCTs to develop the scientific development of moxibustion.

• Journal of Oriental Neuropsychiatry
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• v.21 no.4
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• pp.151-161
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• 2010

Objectives : This study aimed to evaluate any clinical studies regarding the herbal medicine for dementia focusing on Korean literature for future rigorous clinical research. Methods: Every article relevant to dementia was initially obtained from oriental medical related journals by electronic search at journal web sites or manual searches. Journals were limited to those registered with the Korea Research Foundation. From initial findings. two independent reviewers selected clinical articles and these articles were further analyzed separately by predefined criteria according to prospective and retrospective studies. For randomized controlled trial and non randomized controlled trial. quality assessment was also conducted. Results: From ninety seven patients initially obtained articles. twenty three patients were finally analyzed. One article was randomized controlled study. Four articles were prospective whereas eighteen patients were retrospective. In the qualitative evaluation of prospective articles. there was deduction regarding pre-calculated study size and prospective data collecting. Assessment measurement most frequently used was Mini Mental State Examination. The order of frequency of use herbs were identified. Conclusions : According to our study. the herbal medicine for dementia in general showed a positive effect in the cognitive aspects of dementia patients. Further well-designed randomized controlled studies should be conducted.

• Korean Journal of Radiology
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• v.23 no.12
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• pp.1119-1125
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• 2022

• 대한예방의학회:학술대회논문집
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• 2001.10a
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• pp.305-307
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• 2001

• 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.