A 24 weeks, randomized, double-blind, placebo-controlled human trial of Allium fistulosum L. root extract on improvement of child height growth

A 24 weeks, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Allium fistulosum L. root extract on improvement of child height growth

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005981

Enrollment

100

Registered

2021-03-09

Start date

2021-03-11

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : • Allium fistulosum L. root extract group: once a day, 1 tablets once, after breakfast, for 24 weeks(5 g/day, 1 g/day for Allium fistulosum L. root extract) • Placebo group: once

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Children before adolescence, 3~ 25 percentile based on 2017 Korea standard growth chart percentile 2) Spontaneously agreed to participate in the study by the patients and legal guardians or parents

Exclusion criteria

Exclusion criteria: 1) Participants who have taken Hormone replacement therapy or calcitonin, Phosphonate, growth hormone within 6 month prior to the screening examination 2) Participants with a clinically significant disease requiring treatment (i.e., acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, kidney and urinary system, neuropsychiatric system, musculoskeletal inflammation, inflammatory disease, blood and tumor disease, gastrointestinal disease, etc.) 3) Participants who take medicine or health functional food for improvement of child height growth within 3 month prior to the screening examination 4) Participants with a history of antipsychotic medication use within 3 months prior to the screening examination 5) Participantts who have participated in other clinical trials within 3 months prior to the screening examination 6) Participants who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes

Design outcomes

Primary

Measure	Time frame
Height	—

Secondary

Measure	Time frame
IGF-1(Insulin-like growth factor-1);IGFBP-3(Insulin-like growth factor binding protein-3);Growth Hormone	—

Countries

Korea, Republic of

Contacts

Public ContactHyelim Lee

Daejeon Korean Medicine Hospital of Daejeon University

Outcome results