• The Journal of KAIRB
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• v.4 no.2
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• pp.36-41
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• 2022

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

• 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 the Korean Society of Food Science and Nutrition
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• v.41 no.11
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• pp.1554-1558
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• 2012

Method development and validation of ellagic acid for the standardization of Gochang Bokbunja as a functional ingredient and health food were accomplished. A Symmetry$^{(R)}$ (C18, $4.6{\times}250mm$, $5.0{\mu}m$) column was used with a gradient elution system of 1% formic acid in water and acetonitrile. This method was validated according to specificity, linearity, accuracy, precision test, and recovery test. Specificity was confirmed with identical retention time, and calibration curves of ellagic acid showed good linear regression ($R^2$ >0.9996). Relative standard deviations (RSD) of data from the intra- and inter-day experiments were less than 2.28% and 2.84%, except in the low limit of quality control (LLOQ, $1{\mu}g/mL$) sample. The results of the recovery test were from 89.17% to 97.92% with RSD values from 0.05 to 0.14%. Therefore, we performed analysis of ellagic acid as a marker compound in Gochang Bokbunja extracts. The amount of ellagic acid in Gochang Bukbunja was about $1.918{\mu}g/mg$ (0.192%) in the three times analysis, and RSD was less than 2.36% by the validated method. These results suggest that the developed HPLC method is simple, efficient, and could contribute to the quality control of Gochang Bokbunja extract as a functional ingredient.

• Clinical Endoscopy
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• v.55 no.2
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• pp.210-212
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• 2022

• The Journal of Internal Korean Medicine
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• v.28 no.3
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• pp.519-530
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• 2007

Objectives : The purpose of this study was to develop outcome indicators in clinical trials of herbal drugs effective for asthma. cough and sputum. To accomplish the objective, this study collected outcome indicators developed and used according to conventional medical concepts. Methods : Our research group reviewed SCI papers concerned with developing outcome indicators to evaluate amelioration of asthma, cough and sputum. We also reviewed clinical trials of herbal drugs effective for them. Results : To evaluate asthma, objective as well as subjective methods were chosen according to the purpose of each trial. Objective methods were PEF, FEVl, serum IgE, peripheral eosinophil counts, and so on. Subjective methods were symptom scores, symptom diaries, quality of life measures, etc. To evaluate cough and sputum, objective and subjective methods were also chosen. Objective methods were tussigenic challenges, sputum induction and computerized methodology, and subjective methods were similar to the methodology evaluating asthmatic symptoms. Conclusions : It is desirable for a clinical trial evaluating herbal drugs for asthma, cough and sputum to use objective and subjective outcome indicators together. However, biological outcome indicators, a kind of objective methods, can not be chosen as the purpose of trial. Valid and reliable subjective outcome indicators are needed to develop good clinical trials of herbal drugs effective for asthma, cough and sputum.

• Clinical Nutrition Research
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• v.13 no.1
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• pp.22-32
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• 2024

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings.

• The Journal of Korean Obstetrics and Gynecology
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• v.33 no.4
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• pp.75-92
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• 2020

Objectives: This clinical trial is performed to investigate the effect of improving the menopausal symptoms and the safety of extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. in menopausal women Methods: This study was randomized, double blinded, placebo-controlled clinical trial. 110 women with menopausal symptoms were assigned to treatment group (n=55) and control group (n=55). The results of this study were evaluated through changes in Kupperman Index score, Menopause-specific Quality of Life Questionnaire (MENQOL) score, degree of hot flashes and sweating, Body Mass Index(BMI), laboratory test results including female hormones. Results: In the treatment group compared to before baseline, there was significant difference in the Kupperman Index total score, score of each item in the Kupperman Index, MENQOL total score, hot flush and sweating visual analogue scale (VAS), hot flush score, and hot flush duration at one time. However, there was also a significant change compared to baseline in the control group, there was no significant difference between the treatment group and the control group. There was no significant change in female hormone levels in both group, and there were no adverse events associated with the clinical trial product. Conclusions: This clinical trial showed that extract obtained from Pueraria thunbergiana Bentham and Curcuma longa L. was helpful in improving menopausal symptoms in menopausal women without significant side effects.

• Journal of Ginseng Research
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• v.42 no.1
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• pp.90-97
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• 2018

Background: Antihyperglycemic effects of Panax ginseng berry have never been explored in humans. The aims of this study were to assess the efficacy and safety of a 12-wk treatment with ginseng berry extract in participants with a fasting glucose level between 100 mg/dL and 140 mg/dL. Methods: This study was a 12-wk, randomized, double-blind, placebo-controlled clinical trial. A total of 72 participants were randomly allocated to two groups of either ginseng berry extract or placebo, and 63 participants completed the study. The parameters related to glucose metabolism were assessed. Results: Although the present study failed to show significant antihyperglycemic effects of ginseng berry extract on the parameters related to blood glucose and lipid metabolism in the total study population, it demonstrated that ginseng berry extract could significantly decrease serum concentration of fasting glucose by 3.7% (p = 0.035), postprandial glucose at 60 min during 75 g oral glucose tolerance test by 10.7% (p = 0.006), and the area under the curve for glucose by 7.7% (p = 0.024) in those with fasting glucose level of 110 mg/dL or higher, while the placebo group did not exhibit a statistically significant decrease. Safety profiles were not different between the two groups. Conclusion: The present study suggests that ginseng berry extract has the potential to improve glucose metabolism in human, especially in those with fasting glucose level of 110 mg/dL or higher. For a more meaningful benefit, further research in people with higher blood glucose levels is required.

• Journal of Gastric Cancer
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• v.12 no.1
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• pp.7-12
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• 2012

More than ten years have passed since the sentinel node (SN) concept for gastric cancer surgery was first discussed. Less invasive modified surgical approaches based on the SN concept have already been put into practice for malignant melanoma and breast cancer, however the SN concept is not yet placed in a standard position in gastric cancer surgery even after two multi-institutional prospective clinical trials, the Japan Clinical Oncology Group trial (JCOG0302) and the Japanese Society for Sentinel Node Navigation Surgery (SNNS) trial. What is the problem in the clinical application of the SN concept to gastric cancer surgery? There is no doubt that we need reliable indicator(s) to determine with certainty the absence of metastasis in the lymph nodes in order to avoid unnecessary lymphadenectomy. There are several matters of debate in performing the actual procedure, such as the type of tracer, the site of injection, how to detect and harvest, how to detect metastases of SNs, and learning period. These issues have to be addressed further to establish the most suitable procedure. Novel technologies such as indocyanine green (ICG) fluorescence imaging and one-step nucleic acid amplification (OSNA) may overcome the current difficulties. Once we know what the problems are and how to tackle them, we can pursue the goal.

• Clinical and Experimental Pediatrics
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• v.55 no.11
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• pp.403-407
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• 2012

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.