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 Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP -

소아 청소년 만성기침 환자를 대상으로 한 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 Jun-Hwan (KM Science Research Division, Korea Institute of Oriental Medicine ) ;
  • 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) ;
  • 이준환 (한국한의학연구원 한의과학연구부) ;
  • 이보람 (한국한의학연구원 한의과학연구부) ;
  • 장규태 (경희대학교 대학원 한방소아과)
  • Received : 2023.07.25
  • Accepted : 2023.08.21
  • Published : 2023.08.31
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Abstract

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

Keywords

Acknowledgement

본 연구는 보건복지부의 재원으로 한국보건산업진흥원의 보건의료기술연구개발사업 지원에 의하여 이루어진 것임 (과제고유번호: HF22C0011).

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