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

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

김영미|이혜림|이정한|고병섭|육진아|심수보|이호봉|하기찬
대한한방소아과학회 (The Association of Pediatrics of Korean Medicine)|2021.05|대한한방소아과학회지 (The Journal of Pediatrics of Korean Medicine)|제35권 제2호|pp. 11-20

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참고문헌

키워드

Clinical trialGrowthProtocolShort statureAllium Fistulosum extract
주제분류한의학

초록

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.

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.

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관련 논문AI추천

소아 키 성장에 미치는 한삼덩굴추출분말의 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜최봄, 김기봉, 장수비, 천진홍대한한방소아과학회 · 대한한방소아과학회지2023 · 제37권 제3호발효굴추출물의 경구 섭취가 소아 신장 성장에 미치는 효과 및 안전성 평가를 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜김기봉, 김희연, 박범찬, 박정현, 안병민, 이배진, 천진홍, 최준용대한한방소아과학회 · 대한한방소아과학회지2019 · 제33권 제4호한약제제의 골성장 효과에 대한 국내외 실험 연구 고찰권나연, 김동연, 김태정, 성현경, 양희원, 이동녕, 최동건대한한방소아과학회 · 대한한방소아과학회지2021 · 제35권 제3호한의 성장 치료에 따른 성장 지표 변화오혜인, 이현희, 이혜림, 정지은대한한방소아과학회 · 대한한방소아과학회지2023 · 제37권 제3호소아 성장을 위한 한약 투여에 대한 후향적 연구김지은, 백정한대한한방소아과학회 · 대한한방소아과학회지2016 · 제30권 제4호Refining growth intervention targets: percentilebased efficacy analysis of fermented oyster extract (FGO) in pediatric short stature김재일, Bae-Jin Lee, Kyoung-Min Rheu한국수산과학회 · Fisheries and Aquatic Sciences2025 · 제28권 제11호

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