KCT0001714招募中未知
A 12-week, randomized, multi-center, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of bamboo shavings (Phyllostachyos Caulis in Taeniam) extract on improvement of height growth
Korea Medicine Research Institute0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 6(Year) 至 11(Year)（—）
- 性别
- All
入选标准
- •1) Children aged 6 to 11 years
- •2) Children before adolescence, 3~ 25 percentile based on 2007 standard growth chart percentile
- •3) A suitable people to apply the clinical trial subject through a physical examination, interview conducted in accordance with the study protocol
- •4) A suitable people to apply the clinical trial subject through a blood, urine test conducted in accordance with the study protocol
- •5) Spontaneously agreed to participate in the study by the patients and legal guardians or parents
排除标准
- •1) Children who have taken growth hormone within the last 6 month prior to the first visit of the study
- •2) Children who have growth retardation caused by endocrine disorders (growth hormone deficiency, hypothyroidism, type 1 diabetes mellitus etc.)
- •3) Children who have intrauterine growth retardation
- •4) Children who have taken functional foods (vitamin D, K, Ca) within the last 4 weeks prior to the baseline visit of the study for growth
- •5) Children who have taken drug (hyperlipidemia, endocrine system, endocrinotherapy) within the last 4 weeks prior to the baseline visit of the study for growth
- •6) Children with gastric disease or gastrointestinal surgery
- •7) Children with diseases as follows: hepatic diseases, pancreas diseases, renal diseases, nervous system diseases, respiratory system diseases, endocrine system diseases, hemato-oncology, mental illness, cardiovascular disease
- •8) Known hypersensitivity to study product or any ingredient in study product.
- •9) Children with following diseases
- •- Aspartate transaminase(AST) or Alanine transaminase(ALT) = the upper limit of normal levels (ULN)?1.5
- •- Total bilirubin = the upper limit of normal levels (ULN)?1.5
- •- Serum creatinine= the upper limit of normal levels (ULN)?1.5
- •- Creatine kinase = the upper limit of normal levels ULN)?1.5
- •10) Hypertension (Systolic blood pressure(SBP)= 130 mmHg or Diastolic blood pressure(DBP) = 77 mmHg), pulse >100
- •11) Children who have taken ethical drug, oriental medicine within the last 4 weeks or over the counter drug within the last 2 weeks prior to the baseline visit of the study
- •12) Participation in other human study within 2 month prior to the first visit
- •13) Children with any other health concerns
研究者
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