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The Current State of Registration of Interventional Clinical Trials for Children and Adolescents with Precocious Puberty (성조숙증 소아 대상 중재 임상시험의 등록 현황 보고 -Clinicaltrial.gov, WHO ICTPR, CRIS를 중심으로-)

  • Shim, Soo Bo;Seo, Hyun Sik;Lee, Hyun Hee;Lee, Hye Lim
    • The Journal of Pediatrics of Korean Medicine
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    • v.36 no.3
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    • pp.1-18
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    • 2022
  • Objectives The purpose of this study was to investigate the current status of interventional clinical trial registration for children with precocious puberty and to secure basic data for the design of clinical trials for traditional Korean medicine treatment of precocious puberty. Methods The following resources were used to search for data: Clinicaltrial.gov, World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), and Clinical Research Information Service (CRIS), using the search terms, 'Precocious puberty', 'child'. All clinical trials which were registered as of June 2022 were used. Results For the intervention and clinical trial design, gonadotropin releasing hormone (GnRH) analog was reported in 41.7% of trials, and single group assignment was performed in 66.7% of the studies. Prior consent had not been reported in 50% of the studies. Tanner stage and GnRH stimulation tests were reported by multiple trials as inclusion criteria, and prior treatment experiences for trial drugs were reported as exclusion criteria. The peak serum concentration of luteinizing hormone following GnRH stimulation test was used as a primary outcome in 45.8% of clinical trials, and other growth-related indicators such as growth rate, height, and predicted adult height were also reported. Conclusions In consideration of the design, eligibility criteria, and outcome measurement of the existing clinical trials identified in this study, it should be referred to in the design of clinical trials for traditional Korean medicine treatment of precocious puberty.

Comparative Review of Current Clinical Trials on Abdominal Obesity (복부비만 관련 임상시험의 국내외 연구경향 고찰)

  • Lim, Je-Yeon;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine Rehabilitation
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    • v.20 no.2
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    • pp.63-77
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    • 2010
  • Objectives : It is known that abdominal obesity increases the possibility of cardiovascular diseases, early death, and metabolic syndrome including dyslipidemia and insulin resistance. Clinical trials have been under way to verify the effectiveness of treatment for abdominal obesity. The objective of this study is to set criteria about how effective oriental medicine and acupuncture are in abdominal obesity. Methods : I manually search "www.clinicaltrial.gov", 4 Korean medical databases and 4 Korean medical journals of abdominal obesity. Search terms used were "abdominal obesity" or "visceral obesity". In order to see detail review, searching was performed from 01, 01, 2005 to 11, 31, 2009. And I classified all the searched studies into design, intervention, purpose, end point, diseases, condition and etc. Results : 1. I could search total 67 trials in "www.clinicaltrial.gov". I found 9, 10, 13, 8, 6 clinical trial from 2005 to 2009 every year. 2. Test on both gender and adult or adult and senior have been most frequent. 3. Randomization clinical trial is 51 cases that occupied 96.2%. 38 cases use control group. 4. Body mass index(BMI) and waist circunference(WC) are major criteria of abdominal obesity clincal trial. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial. 5. I could search total 86 cases in domestic study. I found 15, 23, 23, 20, 5 cases from 2005 to 2009 every year. 6. Test on female and adult have been most frequent in domestic study. 7. Randomization clincal trial is only 2 cases that occupied 2.3%. 62 cases use control group in domestic study. 8. BMI, body fat percent, WC, visceral-subcutaneous fat ratio(VSR), waist-hip ratio(WHR) are criteria of abdominal obesity clincal trial in domestic study. WC, BMI, abdominal fat mass, body weight are measured at end point of abdominal obesity clincal trial in domestic study. Conclusions : To improve abdominal obesity study in traditional korean medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

The Trend in Clinical Study on Atopic Dermatitis Over the Last 3 Years (아토피 피부염 임상 연구의 최근 3년간 동향)

  • Choi, In-Hwa
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.20 no.3
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    • pp.138-146
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    • 2007
  • Objective : To observe the trend in clinical study on atopic dermatitis(AD) over the last 3 years in order to develop a study methodology of AD in Oriental Medicine. Methods : Using the Pub med on line site; search terms: atopic dermatitis, field as title/abstract, limitation as published in the last 3 years, only items with links to full text, Humans, Clinical Trial, English. I observed the study contents of all this research and focused on the classification of treatments. I also observed of AD clinical trials registered on a clinical trial site(www.clinicaltrial.gov) on 23rd of June, 2007: study contents, localization and study designs. Results : Through the Pub Med site, I found 169 articles. Classified according to study subject, the studies related to treatment were 114(67.5%); physiology, pathology and prevention 12(7.1%); Diagnosis and Evaluation(7.1%); psychological aspects including quality of life 10(5.9%); diet and management 10(5.9%); epidemiology 7(4.1%); and others 7(4.1%). However, the treatment study of herb-medicine as intervention showed only 1 article. Futhermore, it wasn't based on Oriental Medicine philosophy. In the clinical trial site, there were 31 studies in which patients were recruited or planned for the future. The study on efficacy and safety of the medicine produced 14 trials, 5 comparative trials, 2 phototherapy, 2 diagnosis, 6 physiology and pathology, and 2 epidemiology. The trial institutions were concentrated in U.S.A. Conclusion : I suggest we'd better try to make a good clinical guideline and standardization of diagnosis and herb-medicine in order to develop a clinical study methodology of AD as soon as possible in the future. Even though it 's very hard to find the study methodology, we should aim to achieve positive results and show the evidence of the efficacy and safety of herb-medicine treatment for AD using Oriental Medicine.

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Recent Topics of Clinical Trials in Obesity and Metabolic Study (비만과 대사증후군에 관한 임상시험의 최근 경향)

  • Lee, Ju-Ah;Kong, Kyung-Hwan;Ko, Ho-Yeon;Bae, Kwang-Ho;Park, Sun-Young;Park, Kyung-Moo;Song, Yun-Kyung;Park, Jung-Hyeon;Kim, Ho-Jun;Park, Sun-Jun;Park, Jeong-Su;Ko, Seong-Gyu
    • Journal of Korean Medicine for Obesity Research
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    • v.9 no.1
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    • pp.15-22
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    • 2009
  • Objectives The aim of this study is to review and analyze the status on the recent clinical trials of 'obesity' and 'metabolic syndrome'. Methods We search 'www.clinicaltrail.gov' for research trend of Obesity and metabolic syndrome. Search terms used were 'obesity' and 'metabolic syndrome'. In order to see detail review, searching was performed from 01, 01, 2007 to 05, 31, 2009 with intervention, phase III or phase IV, And we classified all the searched studies into design, intervention, purpose, end point, diseases and condition Results We could search total 232 trials. Of them, we found 32 trials with intervention, phase III or phase IV from 01, 01, 2007 to 05, 31, 2009 Also we could see various design of clinical trials. Conclusion To improve obesity and metabolic study in Traditional Korean Medicine, it is need to activate clinical trial, meta analysis, develope of clinical practice guidelines, co-works with conventional medicine and etc.

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