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http://dx.doi.org/10.7778/jpkm.2021.35.2.11

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  

Shim, Soo Bo (Department of Pediatrics, College of Korean Medicine, Daejeon University)
Ko, Byoung Seob (Korean Institute of Oriental Medicine)
Ryuk, Jin Ah (Korean Institute of Oriental Medicine)
Lee, Jung Hwan (WONIL FOOD CO. LTD.)
Lee, Ho Bong (WONIL FOOD CO. LTD.)
Ha, Ki Chan (Healthcare Claims & Management, Incorporation)
Kim, Yeung Mi (Healthcare Claims & Management, Incorporation)
Lee, Hye Lim (Department of Pediatrics, College of Korean Medicine, Daejeon University)
Publication Information
The Journal of Pediatrics of Korean Medicine / v.35, no.2, 2021 , pp. 11-20 More about this Journal
Abstract
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.
Keywords
Allium Fistulosum extract; Short stature; Growth; Clinical trial; Protocol;
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