Children with Insufficient Growth
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children whose height percentile is from P3 to P25; 2. 4<= age <=12, Equal numbers of boys and girls; 3. The legal guardian shall sign the informed consent form before the test. The subjects should also sign the informed consent form for children.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria are not eligible to participate in this trial: 1. There are relatively serious internal diseases such as heart, liver, kidney, glaucoma, benign prostatic hyperplasia, and endocrine disorders; 2. Co-suffering from neurological and developmental disorders such as cerebral palsy, epilepsy, and adrenoleukodystrophy; 3. Co-suffering from severe psychological and mental disorders such as tic disorders, autism spectrum disorders, mental retardation, pervasive developmental disorders, childhood schizophrenia, manic episodes and bipolar disorders, specific learning skills development disorders, Tourette syndrome, etc. 4. Suffering from anemia, craniocerebral malformations, liver and kidney diseases, celiac disease, gastrointestinal diseases (such as gastroesophageal reflux, irritable bowel syndrome, Crohn's disease, etc.), metabolic diseases (such as phenylketonuria) and/or systemic immune diseases; 5. Abnormalities in auxiliary examinations and laboratory tests that the researchers consider to have clinical significance; 6. Having participated in other drug clinical trials within the three months prior to selection; 7. Simultaneously receive growth hormone injection therapy; 8. Antifungal treatment, antibiotic treatment and/or special diets (gluten-free diet, casein-free diet, high-protein diet and ketogenic diet, etc.) were received within 2 months before enrollment; 9. Researchers believe that other comorbidities or medications currently being taken may interfere with the safe application of Zhishigao. 10. At any stage of the research, it is necessary to take psychotropic drugs, including health supplements that the researchers believe have central nervous system activity (such as melatonin (Brain Platinum)); 11. Girls diagnosed with precocious puberty; 12. The researcher believes that the subjects and/or their parents or guardians were unable to fully understand this study or comply with its requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height growth rate within 6 months (cm/ month);Bone age growth rate within 6 months (years/year); | — |
Secondary
| Measure | Time frame |
|---|---|
| IGF-1;IGFBP3; | — |
Countries
China
Contacts
Shanghai Children's Medical Center Affiliated to Shanghai Jiao Tong University School of Medicine