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 Humulus japonicus Extract Powder on Child Height Growth: Study Protocol

소아 키 성장에 미치는 한삼덩굴추출분말의 유효성 및 안전성을 평가하기 위한 무작위배정, 이중눈가림, 위약 대조 인체적용시험: 인체적용시험 프로토콜

  • Jang Subi (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital) ;
  • Choi Bom (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital) ;
  • Cheon Jin Hong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital) ;
  • Kim Ki Bong (Department of Korean Pediatrics, Pusan National University Korean Medicine Hospital)
  • 장수비 (부산대학교한방병원 한방소아과) ;
  • 최봄 (부산대학교한방병원 한방소아과) ;
  • 천진홍 (부산대학교한방병원 한방소아과) ;
  • 김기봉 (부산대학교한방병원 한방소아과)
  • Received : 2023.08.01
  • Accepted : 2023.08.22
  • Published : 2023.08.31
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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.

Keywords

Acknowledgement

본 결과물은 농림축산식품부의 재원으로 농림식품기술기획평가원의 고부가가치식품기술개발사업의 지원을 받아 연구되었음 (No. 121023-3). 본 연구는 2023년도 부산대학교병원 임상연구비 지원으로 이루어졌음.

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