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KMID : 0363420230370030121
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Journal of Korean Oriental Pediatrics
2023 Volume.37 No. 3 p.121 ~ p.132
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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
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Jang Su-Bi
Choi Bom
Cheon Jin-Hong
Kim Ki-Bong
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Abstract
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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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KEYWORD
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Humulus japonicus Extract Powder, Short stature, Growth, Human Study, Protocol
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