• 제목/요약/키워드: Humulus japonicus Extract Powder

검색결과 1건 처리시간 0.017초

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)

  • 장수비;최봄;천진홍;김기봉
    • 대한한방소아과학회지
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    • 제37권3호
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    • pp.121-132
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    • 2023
  • 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.