A 6 month, multi-center, randomized, double-blind, placebo-controlled parallel design human study for the evaluation of the efficacy and safety of HT042 on height promoting in low-height children

Korea Yakult Corporation0 个研究点目标入组 140 人开始时间: 待定最近更新: 2019年3月11日

适应症

试验速览

暂无简介。

•1) Men and women aged 6 to 8 years
•2) children less than 25 percentile based on 2007 standard growth chart percentile due to idiopathic
•3) People who signed the informed consent form before participating in the study

•1)Children have Growth retardation caused by endocrine disorders (Growth Hormone deficiency, Hypothyroidism, type 1 diabetes mellitus etc.)
•2)Children have Precocious Puberty(LH > 0.6 IU/L)
•3)Children being treated with infected, tumor etc.
•4)Children who have taken growth hormone within the last 4 weeks prior to the first visit of the study
•5)Children who have taken functional foods or drugs within the last 2 weeks prior to the first visit of the study for growth
•6)Patient has uncontrollable type 1 diabetes mellitus(Fasting blood glucose levels greater than 126 mg/dl)
•7)TSH, T3, FT4 deviates from the normal value of the hospital
•8)Patient has creatinine value exceeding 2 times of upper limit of the normal range at the hospital
•9)Patient has AST(GOT) or ALT(GPT) value exceeding 2 times of upper limit of the normal range at the hospital
•10)Subjects who are scheduled for another study during this study period
•11)Subjects with any other health concerns

发起方

Korea Yakult Corporation