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

Phase 4

Recruiting

• Conditions: Puberty Changes
• Interventions: Drug: Xuandi Ziyin Mixture

• Registration Number: NCT06820931
• Lead Sponsor: Children's Hospital of Fudan University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-01
• Status Verified: 2025-02
• Study First Submitted: 2025-02-06
• Study First Submitted QC: 2025-02-06
• Last Update Submitted: 2025-02-06
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Xuandi Ziyin Mixture	The intervention group is administered drug therapy for a period of six months.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
AMH	From enrollment to 6 months after treatment.	Anti-Müllerian Hormone (ng/ml, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay.
SHBG	From enrollment to 6 months after treatment.	Sex Hormone Binding Globulin(nmol/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay.

Trial Locations

Locations (1)

Children's Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China