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소아 키 성장에 미치는 한삼덩굴추출분말의 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 Humulus japonicus Extract Powder on Child Height Growth: Study Protocol

김기봉|천진홍|최봄|장수비
대한한방소아과학회 (The Association of Pediatrics of Korean Medicine)|2023.08|대한한방소아과학회지 (The Journal of Pediatrics of Korean Medicine)|제37권 제3호|pp. 121-132

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키워드

GrowthProtocolShort statureHumulus japonicus Extract PowderHuman Study
주제분류한의학

초록

Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

Abstract

Objectives We aimed to confirm whether Humulus japonicus Extract Powder can enhance child height growth significantly and safely compared with a placebo. Methods A total of 150 children between the 3rd and 25th percentiles in height and between the ages of 6 and 9 years will be recruited to participate in this randomized, double-blind, placebo-controlled clinical trial. The participants will be randomly assigned to the treatment or placebo group. Participants in the treatment group will take one pack per day (700 mg of Humulus japonicus Extract Powder) for 24 weeks. Participants in the placebo group will take one package of placebo per day (0 mg of Humulus japonicus Extract Powder) for 24 weeks. The primary outcome will be a change in height after 12 weeks, and the secondary outcomes will be the height after 24 weeks, growth rate, height standard deviation, growth hormone, insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein-3 (IGFBP-3), bone alkaline phosphatase (BALP), and osteocalcin after 12 and 24 weeks. Results This protocol was approved by the Institutional Review Board (IRB) of the Korean Medicine Hospital of Busan University (IRB No. PNUKHIRB-2023-03-002). Research participants will be recruited from June 2023 to December 2023. Conclusions The results of this study provide clinical information regarding the effectiveness and safety of the Humulus japonicus Extract Powder in increasing child height.

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발효굴추출물의 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 제4호총백추출물의 어린이 키 성장에 대한 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜고병섭, 김영미, 심수보, 육진아, 이정한, 이혜림, 이호봉, 하기찬대한한방소아과학회 · 대한한방소아과학회지2021 · 제35권 제2호한의 성장 치료에 따른 성장 지표 변화오혜인, 이현희, 이혜림, 정지은대한한방소아과학회 · 대한한방소아과학회지2023 · 제37권 제3호한약제제의 골성장 효과에 대한 국내외 실험 연구 고찰권나연, 김동연, 김태정, 성현경, 양희원, 이동녕, 최동건대한한방소아과학회 · 대한한방소아과학회지2021 · 제35권 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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