• 대한한방소아과학회지
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• 제37권3호
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• pp.121-132
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• 2023

Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

• 동의신경정신과학회지
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• 제29권4호
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• pp.255-266
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• 2018

Objectives: The objective of this study was to evaluate the reliability and validity of Pattern Identifications Tool for Cognitive Disorders (PIT-C) and verify the correlation with other related scales. Methods: The study in this protocol is a single group, prospective, observational one. The subjects of the study were men and women between the ages of 45 and 85, diagnosed with neurocognitive disorders by Diagnostic and Statistical Manual of Mental Disorder (fifth Edition) criteria (n=60, Clinical Dementia Rating (CDR)=0.5, Korean Version of Montreal Cognitive Assessment $(MoCA-K){\leq}22$). The reliability of PIT-C was evaluated as test-retest and inter-rater reliability. And correlation between PIT-C and other related scales was also assessed. Results: This study was approved by the Institutional Review Board (IRB) of Dunsan Korean Medicine Hospital of Daejeon University and registered in the Clinical Research Information Service (CRIS), and was made public in advance to ensure transparency of the research process and conduct ethical clinical trials. Conclusions: The results of this study can be used to classify neurocognitive disorders as Korean medicine and PIT-C will be helpful tool for primary health care.

• 대한예방한의학회지
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• 제26권3호
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• pp.97-108
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• 2022

Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4^th week, and 6^th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

• 한방안이비인후피부과학회지
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• 제37권2호
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• pp.14-26
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• 2024

Objectives : The purpose of this study is to assess the feasibility of conducting a study on traditional Korean medicine treatments for periodontal diseases, specifically gingivitis and mild periodontitis. Methods : This study will employ a randomized, controlled, parallel-group design. Subjects with gingivitis and mild periodontitis will be recruited in one university hospital. In total, 45 subjects will be randomized into three arms (Acupuncture therapy group, herbal mouthwash group and usual care group), and will be followed up for 4 weeks. We will assess clinical variables such as, pocket depth, bleeding on probing, gingival index, plaque index, visual analog scale, uroqol-5 dimensions-5 levels to analyze changes in microbial flora before and after the intervention. Results : The protocol for this study was approved by the Institutional Review Board (IRB) of Dongguk University Ilsan Oriental Medicine Hospital, and registered with the Korean Clinical Trial Registry on March 29, 2024. Conclusions : This study is the first clinical research on periodontal diseases conducted in a Korean traditional medicine institution. The research aims to broaden the scope of traditional Korean medicine and is expected to serve as crucial data for future large-scale studies.

• 대한한방소아과학회지
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• 제35권2호
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• pp.11-20
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• 2021

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

• 한방비만학회지
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• 제8권2호
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• pp.63-72
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• 2008

Objectives We aimed to explore obesity pattern among overweight and obese Korean adult women using oriental obesity pattern identification questionnaire. Methods This survey was performed using data of 83 overweight and obese women aged from 20 to 55 yrs (BMI ${\geq}\;23\;kg/m^2$ : n=18, BMI ${\geq}\;25\;kg/m^2$ :ｎ=65) in Seoul, from 2007 to 2008. Subjects were given written consent and this study was performed under the permission of institutional review board of Kyung-Hee East-west Neo Medical Center. Results 1. The distribution of oriental obesity pattern identification did not show any differences between obese and overweight group(p>0.05). 2. The ratio of significantly-scored oriental pattern identification was ordered by Stagnation of the liver Qi(肝欝, 21.7%) > Indigestion(食積, 18.1%) > Spleen deficiency(脾虚, 16.9%) > Yang deficiency(陽虚, 14.5%) (n=83). 3. The frequency of top-scored oriental obesity pattern was ordered by Stagnation of the liver Qi(肝欝, 36.1%) > Indigestion(食積, 24.1%) > Yang deficiency (陽虚, 15.7%) (n=83). 4. The frequency of oriental obesity pattern identification was ordered by Stagnation of the liver Qi(肝欝, 41.7%) > Indigestion(食積, 29.2%) > Yang deficiency(陽虚, 12.5%) > Stagnation of the liver Qi and Yang deficiency(肝欝兼陽虚, 8.3%) (n=24). Conclusions In Korean adult overweight and obese women, Stagnation of the liver Qi(肝欝), Indigestion(食積), and Yang deficiency (陽虚) were found to be the main pathology based on oriental obesity pattern identification questionnaire. It suggests that not only physical status but also general condition and emotional problem should be concerned in treatment of obesity. This study could play a role as a preliminary data of oriental obesity pattern identification.

• 통상정보연구
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• 제13권2호
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• pp.151-176
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• 2011

본 연구는 한국의 중재현황을 살펴본 뒤 최근의 학문적 추세를 고려하여 학문융합적 연구방법을 통하여 중재를 연구하는 것이 미래 중재연구방향에 있어 중요함을 밝히고 있다. 한국의 중재현황을 살펴보면, 첫째는 한국의 교역규모와 교역상대국이 증가함에 따라서 분쟁이 증가하면서 중재가 중요한 분쟁해결방식으로 부상하고 있다는 점이다. 둘째, 분쟁의 원인을 살펴보면 대금결제와 매매계약과 관련된 분쟁이 가장 큰 원인이라는 점이다. 셋째, 분쟁당사국들도 유럽을 포함해서 수가 늘어나고 있다는 점이다. 이러한 특정들은 중재를 하나의 학문적 방법론에만 의지해서 연구하는 것이 충분치 않다는 점을 나타내고 있다. 본 연구에서는 학문융합적 중재연구프로그램을 제시하였다. 본 연구는 학문융합적 방법론으로 법학적 방법론, 제도적 방법론, 문화적 방법론, 인과적 방법론, 실증적 방법론을 제시하였으며, 이러한 방법론들을 중재에 도입하여 중재를 학문 융합적으로 분석할 것을 제안하였다. 전통적으로는 법학적 방법론이 중재연구에서 주로 사용한 방법론이었지만 향후 중재는 그 외의 다양한 방법론을 통해서 연구하는 것이 바람직해 보인다.

• 대한한의학회지
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• 제36권3호
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• pp.23-34
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• 2015

Objectives: This study is aimed at assessing the reliability of a standard instrument of diagnosis and assessment for Spleen Qi deficiency pattern questionnaire (SQDQ) and examining the validity of the SQDQ by comparing the pattern identification scores of different groups. Methods: We conducted a survey of 72 participants (60 patients with chronic dyspepsia and 12 healthy subjects) using self-reported questionnaire. Participants were given written consent and this study was performed under the permission of institutional review board of Kyung-Hee university Korean medicine hospital. Results: The reliability and the validity of the questionnaire were inspected. Internal consistency of the SQDQ was excellent. Construct validity analyzed by exploratory factor analysis produced 4 factors, which were selected from eigenvalues that are greater than 1.0. The factor 1, 2, 3 and 4 showed 'fatigue', 'meal', 'diagnosis' and 'figure' respectively. For most of SQDQs' items, there were significant differences observed between the Spleen Qi and the non-Spleen Qi groups. However, the 'emaciation', 'tongue diagnosis' and 'pulse diagnosis' showed no significant differences. Conclusions: The SQDQ restructured in this study may provide a fundamental questionnaire and a further study is required for a more advanced, standardized and statistically proven questionnaire.

• Integrative Medicine Research
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• 제6권3호
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• pp.317-324
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• 2017

Background: Bu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. Methods: This study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. Discussion: The results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT.

• 대한기관윤리심의기구협의회지
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• 제6권1호
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• pp.5-16
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• 2024

Purpose: The purpose of this study is to investigate the current status of pediatric assent in nationwide hospitals and to assess the children's comprehension for pediatric assent by interviewing pediatricians/pediatric neurologists to determine whether children of the age (elementary and middle school students) can understand the purpose, risks, benefits, and concepts of voluntary participation in clinical research described in the assent form, and to help improve the administrative efficiency of multicenter clinical trials. Methods: The status of pediatric assent was surveyed online using Google Forms at 141 university hospitals with administrative staff who are members of the Institutional Review Board (IRB) administrative staff subcommittee with in Korean Association of Institutional Review Boards (KAIRB). Additionally, face-to-face interviews were conducted with 7 pediatricians/pediatric neurologists. Survey and interview responses were summarized using descriptive statistics. Results: Out of the 141 institutions surveyed, 35 institutions (24.8%) responded. Among them, 30 institutions (85.7%) reported having age criteria for acquiring pediatric assent forms in the case of children. The age range for pediatric assent acquisition have been from 7 years old to 12 years old (15 institutions, 50%), and from 7 years old to 15 years old (7 institutions, 23.3%). Nine institutions (25.7%) have had criteria for obtaining both parents' consent in cases involving the participation of children. Nineteen institutions (54.3%) have had checklists or guidelines available for use by IRB members in study protocols involving vulnerable research subjects. Three pediatricians/pediatric neurologists have believed that upper-grade elementary school students (5th-6th grade) could comprehensively understand informed consent forms. Two have believed that middle school students would be able to understand them if they included personal information. Two pediatricians/pediatric neurologists have believed that even lower-grade elementary school students (1st-4th grade) could understand the explanations if they were made simpler. Conclusion: It is suggested that not only elementary school students (7-12 years old) but also middle school students (13-15 years old) should receive pediatric assent forms, as it would facilitate a comprehensive understanding of the forms. To enhance the comprehension of assent form content, it is necessary to use age-appropriate words, language, and expressions in the forms hospital. It is also recommended to create comics or videos to make the content of the assent forms more accessible for children.