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

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

Study Overview

• Status: Recruiting
• Conditions: Puberty Changes
• Intervention / Treatment: Drug: Xuandi Ziyin Mixture

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wen Sun; Phone Number: 8613818844692; Email: sunwenhere@163.com
• Study Contact Backup: Name: Teng Fan; Phone Number: 8619921314120; Email: fantengcn@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Recruiting
      • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; This group does not receive any intervention.
Experimental: Intervention group; The intervention group is administered drug therapy for a period of six months.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of rapid progression type of precocious puberty	The incidence of rapid progression type of precocious puberty between two groups.	From enrollment to 6 months after treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH	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.	From enrollment to 6 months after treatment.
SHBG	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.	From enrollment to 6 months after treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height	The height is measured and obtained by the physician. Place the mechanical height measuring device horizontally on a flat surface, against a wall, and calibrate the height measuring device reading. Instruct the examinee to stand barefoot on the base plate of the height measuring device, facing away from the pillar. When the doctor moves the height measuring device, he holds the handle of the height measuring device, moves horizontally, tries to keep the head upright, and keeps the body and limbs naturally straight. For hair knots and braids that are not convenient to measure height, they should be untied and headwear should be removed. The horizontal pressure plate should be in contact with the head, and the tightness should be moderate. The data is read in cm units and is accurate to 0.1.	From enrollment to 6 months after treatment.
Weight	The weight is measured and obtained by the physician. Place the electronic scale flat on the ground, calibrate the scale reading, instruct the examinee to empty their bowels and bladder, wear light clothing and stand barefoot naturally in the center of the electronic scale pedal, keep the body stable, record the data, the unit is kg, and the value is accurate to 0.1.	From enrollment to 6 months after treatment.
Bone age	Bone age is assessed by a radiologist from our hospital through a standard anteroposterior radiograph of the left hand, and is determined according to the Greulich and Pyle (GP) atlas method. The actual age of the child is stated by the parents and then compared by a specialist doctor from our department. Data entry is performed after verification by two individuals.	From enrollment to 6 months after treatment.
LH	Luteinizing Hormone(U/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.	From enrollment to 6 months after treatment.
FSH	Follicle-Stimulating Hormone(U/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.	From enrollment to 6 months after treatment.
Estradiol	Estradiol(pmol/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.	From enrollment to 6 months after treatment.
Testosterone	Testosterone(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.	From enrollment to 6 months after treatment.
PRL	Prolactin(mIU/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.	From enrollment to 6 months after treatment.
Traditional Chinese Medicine syndrome score	Traditional Chinese Medicine syndrome score is assessed and obtained by a specialized physician. Based on the "Guidelines for the Diagnosis and Treatment of Common Pediatric Diseases in Traditional Chinese Medicine" (Precocious Puberty, ZYYXH/T270-2012) formulated by the China Association of Chinese Medicine and clinical experience, 12 common TCM syndromes for precocious puberty are selected (fear of heat, thirst, facial flushing, "heat in the heart, palms, and soles", preference for fatty and sweet foods, irritability and anger, red and swollen eyes, breast pain, constipation, night sweats, bad breath, red tongue). Each item is worth 2 points, with 2 points for presence, 1 point for improvement, and 0 points for absence. The syndrome score is obtained by adding them together.	From enrollment to 6 months after treatment.
Breast Tanner staging	Breast Tanner staging (obtained by the physician through physical examination). The Tanner staging criteria and standard illustrations are used for definition. Some obese girls may find it difficult to distinguish between breast tissue and fat tissue, so we have all the subjects raise their arms and have professional doctors use visual and palpation methods to assess the breast development stage.	From enrollment to 6 months after treatment.
Uterine volume	Uterine volume obtained through ultrasound measurement; The size and shape of the organs are measured by a professional ultrasound physician from our hospital. The volume is calculated using the formula: V=(π /6)*length*anteroposterior diameter*transverse diameter, with the unit being cubic centimeters (cm³).	From enrollment to 6 months after treatment.
ovarian volume	Ovarian volume obtained through ultrasound measurement The size and shape of the organs are measured by a professional ultrasound physician from our hospital. The volume is calculated using the formula: V=(π /6)*length*anteroposterior diameter*transverse diameter, with the unit being cubic centimeters (cm³).	From enrollment to 6 months after treatment.
follicle diameter	Follicle diameter obtained through ultrasound measurement The size and shape of the organs are measured by a professional ultrasound physician from our hospital.	From enrollment to 6 months after treatment.

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: February 6, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: TCM; puberty
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious
• Other Study ID Numbers: FDCH-ZYXZS-2024313; Z-2019-41-2101-02 (Other Grant/Funding Number: China International Medical Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No