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Clinical Trials in China / NCT06820931
Recruiting Phase 4

Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty

NCT06820931 · tracked via the Priya Life Science China tracker
Sponsor
Children's Hospital of Fudan University
Phase
Phase 4
Started
2025-01-01
Last updated
2025-02-11

Condition(s) studied

Puberty Changes

Investigational drug(s) / intervention(s)

Xuandi Ziyin Mixture

Xuandi Ziyin Mixture: Treatment is given only with the hospital preparation 'Xuandi Ziyin Mixture' with a dosage of 30ml per administration three times a day.

Study summary

1\. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. Assess the therapeutic effect of nourishing yin and purging fire traditional Chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional Chinese medicine

Eligibility

Sex
FEMALE
Min age
8 Years
Max age
9 Years
Healthy volunteers
No
Inclusion Criteria: * Girls with an onset age \>8 years and ≤9 years; * Breast bud Tanner stage II breast bud diameter \<3 cm; * Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm; * Bone age does not exceed actual age by more than 1 year; * LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L. * Good compliance; * Patients and their parents are willing to actively cooperate with the clinical trial; * Legal guardian signs the informed consent form. Exclusion Criteria: * Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.; * Use of treatments that affect gonadal function such as chemotherapy radiotherapy; * Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Children's Hospital of Fudan University Shanghai Shanghai Municipality Recruiting

More Children's Hospital of Fudan University trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06820931 on ClinicalTrials.gov ↗ ← All trials in China