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)
The incidence of rapid progression type of precocious puberty — From enrollment to 6 months after treatment. The incidence of rapid progression type of precocious puberty between two groups.
Trial sites (1)
Facility
City
Region
Status
Children's Hospital of Fudan University
Shanghai
Shanghai Municipality
Recruiting
More Children's Hospital of Fudan University trials in China
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.
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