Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Xuandi Ziyin Mixture.
- Who it may be relevant to
- Registry conditions: Puberty Changes. Basic parameters: 8 years — 9 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Drug 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.
Primary outcome measures
- The incidence of rapid progression type of precocious puberty [Time frame: From enrollment to 6 months after treatment.]
Secondary outcome measures (2)
- AMH [Time frame: From enrollment to 6 months after treatment.]
- SHBG [Time frame: From enrollment to 6 months after treatment.]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT06820931 · FDCH-ZYXZS-2024313 · Z-2019-41-2101-02