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Clinical study of paediatric growth-enhancing formula on short stature children with deficiency of spleen and kidney under P10

Clinical study of paediatric growth-enhancing formula on short stature children with deficiency of spleen and kidney under P10

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400079821
Enrollment
Unknown
Registered
2024-01-12
Start date
2024-02-01
Completion date
Unknown
Last updated
2024-01-14

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

Conditions

Short stature

Interventions

Sponsors

Jiangsu Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: (1)Height below the 10th percentile for the same ethnicity, age, and gender (includes idiopathic short stature, partial growth hormone deficiency, recurrent respiratory infections, functional dyspepsia, etc.); (2)Children with height 5ug/L; (3)Open growth plates; (4)Height growth rate below the 25th percentile (-1SD), specifically: ? 3-4.5 years old: <7cm/year (based on bone age) ? 4.5 years old to puberty: <5cm/year (based on bone age) ? Pubertal children: <6cm/year (based on bone age), without obvious chronic organic diseases; (5)Proportional stature; (6)Normal intellectual development. (7)Slow growth, sparse yellow hair, thin physique, poor appetite, pallid complexion, loose stools, flabby muscles, pale tongue with thin white fur, weak, slow, and forceless pulse. Presence of the main symptom of short stature and at least two other symptoms (including two). (8)Voluntary participation in the trial and signing of an informed consent form.

Exclusion criteria

Exclusion criteria: (1)Clearly diagnosed with systemic, consumptive diseases or chronic diseases of the urinary system, respiratory system, blood system, and endocrine system, etc.; (2)Organic lesions of the central nervous system; (3)Combined chromosomal abnormalities; (4)Presence of bone metabolism abnormalities or history of medication that affects bone metabolism; (5)Allergic to the components of this medication; (6)Currently participating in other drug clinical trials.

Design outcomes

Primary

MeasureTime frame
Standard deviation of height;Standard deviation of growth rate;Predicted lifetime height change;

Secondary

MeasureTime frame
Chinese Medicine Symptom Score;IGF-1;25-(OH)-VD;Intestinal flora 16SrDNA sequencing;Serum SCFA;Faecal SCFA;CD4+;CD8+;VEGF;HMGB1;RANKL;WNTS;BMP3;TGF-ß;AP-1;FGFR;

Countries

China

Contacts

Public ContactJin Ye

Jiangsu Provincial Hospital of Traditional Chinese Medicine

dryejin@163.com+86 139 5163 5213

Outcome results

None listed

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