CTRI/2022/10/046687招募中未知
A 24 week, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of aqueous extract of Phyllostachyos Caulis in Taeniam on height growth in children between the age of 6 to 11 years
Korea Medicine Research Institute0 个研究点目标入组 0 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
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Male or female of 6 to 11 years (both inclusive) of age at the time of screening.
- •2. Pre-adolescence children, diagnosed by a specialist, whose height is in the 3rd to 25th percentile of the standard growth chart (growth curve) as per Indian children.
- •3. Judged to be suitable as subject for clinical trial through self-reporting medical history since birth. That is, children who have no congenital or chronic disease and have no
- •pathological symptoms or findings: Children without endocrine disease, chromosomal abnormality, abnormal appearance, and chronic diseases that cause growth impairment and Children with normal birth weight.
- •4. Judged to be suitable as subjects for clinical trial as a result of diagnostic laboratory medical tests such as hematology, blood biochemistry, and urine tests conducted in
- •accordance with this protocol.
- •5. Voluntarily decides to participate after fully understanding the detailed explanation of this study and agreeing to comply with precautions (children with parents who
- •agreed to the written informed consent). Audio video consent, consent form for parents and assent form for children is required.
排除标准
- •1)Received hormone replacement therapy, cytokine, phosphate, and growth hormone treatment within 6 months prior to screening.
- •2)Health conditions/ diseases that may affect growth retardation such as endocrine diseases (growth hormone deficiency, hypothyroidism, type 1 diabetes, etc.)
- •3)With intrauterine growth retardation (IUGR)
- •4)On therapy of vitamin D, vitamin K, calcium (Ca) supplements, or health functional foods that may affect height growth within 4 weeks before the first dose.
- •5)Use of any hyperlipidemia or endocrine disease related drugs, hormone preparations within 4 weeks before the screening test.
- •6)History of gastrointestinal diseases.
- •7)Any significant history or current evidence of diseases including liver, pancreas, kidney, nervous system, respiratory system, endocrine system, blood/tumor, mental,
- •cardiovascular system, or urinary system; especially those with a history of severe heart disease or major psychiatric disorders such as mania/hypomania or bipolar
- •disorder, depression anxiety disorder, suicidal tendencies and schizophrenia etc.
- •8)History of clinically significant hypersensitivity or intolerance to drugs and health functional foods.
- •9)Any out of the normal range for the following parameters in diagnostic laboratory medical examination: AST or ALT, Total bilirubin, Serum creatinine, Creatine Kinase.
- •10)Any significant values corresponding to hypertension (systolic blood pressure = 130 mmHg or diastolic blood pressure = 77 mmHg) in vital signs, and those with a pulse rate exceeding 120 beats.
- •11)Use of any prescription drugs or herbal medicines within 4 weeks prior to the first administration date or have taken any OTC within 2 weeks (However, if other conditions are appropriate according to the judgment of the principal investigator, if other conditions are reasonable, he/she may participate in the clinical trial).
- •12)Participated in other studies within 2 months before screening.
- •13)Judged as inappropriate to participate in the study due to the results of diagnostic laboratory and medical examinations and other reasons by the principal investigator.
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