The Journal of Pediatrics of Korean Medicine (대한한방소아과학회지)

The Association of Korean Oriental Pediatrics (대한한방소아과학회)
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The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP-

소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -

  • Jeong Yoon Kyoung (Department of Korean Pediatric, Graduate School, Kyung Hee University) ;
  • Choi Seo Yeon (Department of Pediatrics of Korean Medicine, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital at Gangdong) ;
  • Bang Miran (Department of Pediatrics of Korean Medicine, Kyung Hee University College of Korean Medicine, Kyung Hee University Hospital at Gangdong) ;
  • Lee Boram (KM Science Research Division, Korea Institute of Oriental Medicine) ;
  • Chang Gyu Tae (Department of Korean Pediatric, Graduate School, Kyung Hee University)
  • 정윤경 (경희대학교 대학원 한방소아과) ;
  • 최서연 (강동경희대학교병원 한방소아과) ;
  • 방미란 (강동경희대학교병원 한방소아과) ;
  • 이보람 (한국한의학연구원 한의과학연구부) ;
  • 장규태 (경희대학교 대학원 한방소아과)
  • Received : 2024.01.25
  • Accepted : 2024.02.23
  • Published : 2024.02.29
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Abstract

Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Keywords

Acknowledgement

본 연구는 보건복지부의 재원으로 한국보건산업진흥원의 보건의료기술연구개발사업 지원에 의하여 이루어진 것임 (과제고유번호: HF22C0035).

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