None listed
Conditions
Interventions
Dietary Supplement : Take Test food (700 mg/day as Hansam vine extract powder) or placebo(white grape concentrate) once a day, once a day, 24 weeks
Sponsors
Pusan National University Korean Medicine Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) A person aged at least 6 years and less than 9 years of age 2) A person whose height corresponds to at least 3 percentile of the gender and age and less than 25 percentile as of the 2017 Child and Adolescent Growth Chart 3) A person who has agreed to participate in this human body application test before the commencement of the human body application test and signed a written consent form by the subject and parents (or legal representatives)
Exclusion criteria
Exclusion criteria: 1) Persons currently being treated for severe cardiovascular, immune, respiratory, gastrointestinal/hepatic and biliary systems, kidney and urinary systems, nervous systems, musculoskeletal systems, mental, infectious diseases and malignancies 2) A person diagnosed with diseases requiring growth hormone treatment (such as growth disorders caused by chronic renal failure, Turner syndrome, Prader-Willie syndrome, fetal development failure, idiopathic hypodilation, and Noonan syndrome) 3) A person diagnosed with endocrine diseases (growth hormone deficiency, hypothyroidism, rickets, pituitary abnormalities, etc.) that may affect growth delay 4) A person diagnosed with unstable and uncontrolled medical conditions (hypertension, diabetes, thyroid disease, etc.) 5) A person whose gestational period is not more than 37 weeks or whose weight is not more than 2.5 kg at birth 6) Tanner Stage 2 or higher 7) A person who has experienced a sudden change in weight within 3 months on the basis of visit 1 8) A person who has administered hormones related to height growth (growth hormone, thyroid hormone, adrenal cortical hormone, sex hormone, etc.) within four weeks of visit 1 9) A person who has administered ADHD drugs (Methylphenate, etc.) within 4 weeks of visit 1 10) A person who has used medicines/Chinese medicine and health functional foods related to height growth within 3 months based on Visit 1 11) As of the 2017 Child and Adolescent Growth Chart, a person whose BMI is above 95 percentile of the gender and age, or whose weight is below 5 percentile of the gender and age 12) People with anemia (Hemoglobin is less than 11.5 g/dL) 13) A person whose creatine is more than twice the normal upper limit of the implementation agency 14) A person whose AST (GOT) or ALT (GPT) is more than twice the upper limit of the agency's normal limit 15) A person who is sensitive or allergic to food ingredients for this human application test 16) A person who has participated in another interventional clinical trial (including human-applied trials) within three months of the visit 1 or who plans to participate in another interventional clinical trial (including human-applied trials) after the start of this human-applied trial 17) A person who is deemed inappropriate by the tester for the human body application test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| height after 12 weeks of intake | — |
Secondary
| Measure | Time frame |
|---|---|
| height after 24 weeks of intake;growth rate after 12, 24 weeks of intake;standard score of height by age after 12, 24 weeks of intake;growth-related indicators (Growth Hormone, IGF-1, IGFBP-3);bone formation indicators (Osteocalcin, BALP) after 12 weeks after intake, and 24 weeks after intake | — |
Countries
Korea, Republic of
Contacts
Public Contactkibong Kim
Pusan National University Korean Medicine Hospital
Outcome results
None listed