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Traditional Chinese Medicine for Rapidly Progressing Early Puberty in Girls

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What is being tested

Xuandi Ziyin Mixture

Drug
Who is being recruted

From 8 to 9 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Phase 4
Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorChildren's Hospital of Fudan University
Study ContactWen SunMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2025

Actual date on which the first participant was enrolled.

This study focuses on girls experiencing early puberty, particularly those with a rapidly progressing type. Researchers aim to see if two specific hormones, AMH and SHBG, are expressed differently before and after the diagnosis of rapid and slow progression types of early puberty. The goal is to determine if these differences can help predict which girls might experience rapid progression. The study also looks at how traditional Chinese medicine, specifically treatments that nourish yin and reduce fire, can be effective for these girls. Understanding these factors is important for developing better diagnosis and treatment guidelines for early puberty using traditional Chinese medicine. Participants in the study will receive traditional Chinese medicine treatments designed to nourish yin and reduce fire. The study will monitor changes in the expression of the hormones AMH and SHBG before and after treatment to evaluate the effectiveness of this approach. By comparing these hormone levels, researchers aim to assess whether this traditional medicine treatment has a therapeutic effect on girls with rapidly progressing early puberty. The study seeks to provide a standardized clinical basis for using traditional Chinese medicine in treating this condition.

Official TitleIndicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
NCT06820931
Principal SponsorChildren's Hospital of Fudan University
Study ContactWen SunMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 8 to 9 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

8 inclusion criteria required to participate
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;

Show More Criteria

3 exclusion criteria prevent from participating
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 Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Children's Hospital of Fudan University

Shanghai, ChinaOpen Children's Hospital of Fudan University in Google Maps
Recruiting
One Study Center