The Journal of Pediatrics of Korean Medicine (대한한방소아과학회지)

The Association of Korean Oriental Pediatrics (대한한방소아과학회)
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Randomized, Double-blind, and Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Fistulosum L. Root Extract on Improvement of Child Height Growth: Study Protocol

총백추출물의 어린이 키 성장에 대한 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜

  • 심수보 (대전대학교 한의과대학 소아과학교실) ;
  • 고병섭 (한국한의학연구원) ;
  • 육진아 (한국한의학연구원) ;
  • 이정한 ((주)원일식품) ;
  • 이호봉 ((주)원일식품) ;
  • 하기찬 (헬스케어크레임스엔드멘내지멘트(주)) ;
  • 김영미 (헬스케어크레임스엔드멘내지멘트(주)) ;
  • 이혜림 (대전대학교 한의과대학 소아과학교실)
  • Received : 2021.03.26
  • Accepted : 2021.05.21
  • Published : 2021.05.31
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Abstract

Objectives The purpose of the study is to evaluate the safety of the Allium Fistulosum extract in children and its effectiveness in height growth. Methods This study is randomized, double-blind, placebo-controlled trial. The participants are children between the 3rd and 25th percentiles in height, and between the ages of 5 and 12 years. They are randomly assigned to treatment group or control group. The treatment group will take 5 g (1 g as Allium Fistulosum extract) for 24 weeks, 1 time a day. The control group will take the 5 g (0 g as Allium Fistulosum extract) of placebo for 24 weeks, 1 time a day. The primary outcome is change in height, and the secondary outcomes are growth rate, height standard deviations, Insulin-like growth factor-1 (IGF-1), Insulin-like growth factor binding protein-3 (IGFBP-3), IGF1-1/IGFBP-3 ratio, growth hormone, bone age, osteocalcin, and Z-score for growth. Results This protocol has been approved by the institutional review board (IRB) of Daejeon Korean Medicine Hospital of Daejeon University (IRB No. DJDSKH-20-BM-15), and registered in the Clinical Research Information Service (CRIS) (Registry No. KCT0005981). Conclusions This study will provide clinical information about the effectiveness and safety of Allium Fistulosum extract in children for their growth.

Keywords

Acknowledgement

본 논문은 2020년 과학기술정보통신부 재원으로 연구개발특구진흥재단 (INNOPOLIS Foundation)의 지원을 받아 수행된 연구임 (2020-DD-RD-0413).

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