The Journal of Pediatrics of Korean Medicine (대한한방소아과학회지)

The Association of Korean Oriental Pediatrics (대한한방소아과학회)
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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 (Gune Branch Office of a Wando County Health Center and Hospital) ;
  • Seo, Hyun Sik (Dept. of Internal Medicine, Daejeon Korea medicine Hospital of Dae-Jeon University) ;
  • Lee, Hyun Hee (Department of Paediatrics, College of Korean Medicine, Daejeon University) ;
  • Lee, Hye Lim (Department of Paediatrics, College of Korean Medicine, Daejeon University)
  • 심수보 (완도군 보건의료원 군외보건지소) ;
  • 서현식 (대전대학교 부속 대전한방병원 내과) ;
  • 이현희 (대전대학교 한의과대학 소아과학교실) ;
  • 이혜림 (대전대학교 한의과대학 소아과학교실)
  • Received : 2022.07.07
  • Accepted : 2022.08.29
  • Published : 2022.08.31
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Abstract

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.

Keywords

Acknowledgement

본 연구는 보건복지부 재원으로 한국보건산업진흥원의 한의표준임상진료지침개발 사업 지원에 의하여 이루어진 것임 (no. HF20C0183)

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