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KMID : 0363420210350020011
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Journal of Korean Oriental Pediatrics
2021 Volume.35 No. 2 p.11 ~ p.20
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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
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Shim Soo-Bo
Ko Byoung-Seob
Ryuk Jin-Ah
Lee Jung-Hwan
Lee Ho-Bong
Ha Ki-Chan
Kim Yeung-Mi
Lee Hye-Lim
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Abstract
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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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KEYWORD
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Allium Fistulosum extract, Short stature, Growth, Clinical trial, Protocol
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