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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-02-28

Brief Summary

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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

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Detailed Description

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Conditions

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Puberty Changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

In this study, 80 patients with premature puberty are included by simple randomization. The randomization scheme is generated by an independent statistical team from the Clinical Trial Center of Children's Hospital of Fudan University using SAS 9.4 software. The intervention protocol determined by the random allocation sequence will be managed by a central coordinator who is not involved in the implementation of the intervention or outcome assessment. The central coordinator will inform the researchers involved in the study of the allocation scheme for the study subjects in accordance with the order in which the guardians of the study subjects sign the informed consent form. The doctor in charge of outcome assessment is completely unaware of the group assignment of the study subjects.

Study Groups

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Control group

This group does not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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

Group Type EXPERIMENTAL

Xuandi Ziyin Mixture

Intervention Type DRUG

Treatment is given only with the hospital preparation 'Xuandi Ziyin Mixture' with a dosage of 30ml per administration three times a day.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

9 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No