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Observation and study on the clinical efficacy of BL-11 intervention in children with idiopathic short stature

Observation and study on the clinical efficacy of BL-11 intervention in children with idiopathic short stature

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500100333
Enrollment
Unknown
Registered
2025-04-08
Start date
2025-04-10
Completion date
Unknown
Last updated
2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ISS,Idiopathic short stature

Interventions

Children with idiopathic short stature treated with recombinant human growth hormone:None
Children with idiopathic short stature who have not been treated with BL-11:NA
Children with idiopathic short stature treated with BL-11:None

Sponsors

West China Second University Hospital of Sichuan University (WCSUH- SCU)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Those who meet the diagnostic criteria for ISS in the 8th edition of "Zhufutang Practical Pediatrics" (height is more than 2 standard deviations (SD) lower than the reference height of normal children, growth rate is less than 5cm/year, bone age is normal or delayed, and growth hormone peak is not less than 10 µ g/L); 2. Individuals aged 4-12 years old, all in the early stage of puberty (male testicular volume <= 4 mL, female breast development in Tanner stage I); 3.Individuals who have not used corticosteroids, gamma aminobutyric acid, or other related therapeutic drugs within the first 3 months of enrollment; 4.The families of the sick children all agreed to participate in this study.

Exclusion criteria

Exclusion criteria: 1. incomplete clinical data; 2. Lost to follow-up during treatment; 3. Chromosomal abnormalities exist; 4. Suffering from other underlying diseases, such as endocrine system diseases, skeletal system diseases, kidney system diseases, cardiovascular system diseases, genetic metabolic diseases, psychosomatic disorders, malnutrition, etc; 5. Family members or patients refuse to participate in this study.

Design outcomes

Primary

MeasureTime frame
Height growth during treatment (cm/year);

Secondary

MeasureTime frame
Serum growth factor levels;25 hydroxyvitamin D levels;Adverse reaction incidence rate;Bone metabolism index level;Progress of bone age;

Countries

China

Contacts

Public ContactFan Yang

West China Second University Hospital of Sichuan University (WCSUH- SCU)

506742295@qq.com+86 18180609105

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026