None listed
Conditions
Interventions
Intervention1: Extract of Phyllostachyos Caulis in Taeniam: 2000 mg thrice daily for 24 weeks
Control Intervention1: Placebo: 2000 mg thrice daily for 24 weeks
Sponsors
Korea Medicine Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Height 2. Standard Deviation Score (SDS) of heightTimepoint: 1. Visit 2,3,4,5 and 6 2. Visit 2 and 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone age - Chronological ageTimepoint: Visit 2 and 6;IGF-1Timepoint: Visit 2 and 6;IGF-1 / IGFBP-3 ratioTimepoint: Visit 2 and 6;IGFBP-3Timepoint: Visit 2 and 6;OsteocalcinTimepoint: Visit 2 and 6 | — |
Countries
India
Contacts
Public ContactSubham Dutta
Syncorp Health Pvt Ltd
Outcome results
None listed