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Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty | Clinical Trials | Clareo Health

RECRUITINGPHASE4

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

NCT06820931•Children's Hospital of Fudan University

View on ClinicalTrials.gov

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

Age

8 - 9 years

Sex

FEMALE

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.

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 1, 2025

Primary Completion Date

December 31, 2025

Completion Date

February 28, 2026

Last Updated

February 11, 2025

Enrollment

ESTIMATED participants

Conditions

Puberty Changes

Interventions

Xuandi Ziyin Mixture

DRUG

Contacts

Wen Sun

CONTACT

8613818844692 sunwenhere@163.com

Teng Fan

CONTACT

8619921314120 fantengcn@163.com

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Puberty ChangesMenstrual Hygiene

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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