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

Fudan University

Status and phase: Enrolling; Phase 4

Conditions: Puberty Changes

Treatments: Drug: Xuandi Ziyin Mixture

Study type: Interventional

Funder types: Other

Identifiers

NCT06820931

FDCH-ZYXZS-2024313

Z-2019-41-2101-02 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: Female

Ages: 8 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Control group

No Intervention group

Description:

This group does not receive any intervention.

Intervention group

Experimental group

Description:

The intervention group is administered drug therapy for a period of six months.

Treatment:

Drug: Xuandi Ziyin Mixture