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

RecruitingPhase 4Ages 8 Years - 9 YearsFemaleChildren's Hospital of Fudan University
NCT06820931 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Xuandi Ziyin Mixture
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Where

1 site
Children's Hospital of Fudan University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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