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KMID : 0363420230370030075
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Journal of Korean Oriental Pediatrics
2023 Volume.37 No. 3 p.75 ~ p.93
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The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP -
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Jeong Yoon-Kyoung
Choi Seo-Yeon
Bang Mi-Ran
Lee Jun-Hwan
Lee Bo-Ram
Chang Gyu-Tae
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Abstract
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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.
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KEYWORD
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Chronic cough, Children, ICTRP, Registry, Clinical trial, Interventional study
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