Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type

Not Applicable

Not yet recruiting

• Conditions: Precocious Puberty

• Registration Number: NCT07141615
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-19
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-26
• Last Update Posted: 2025-08-26
• Study Start: 2025-09-22
• Primary Completion: 2027-11-16
• Study Completion: 2027-12-16

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 94

Inclusion Criteria

• 1. With reference to the diagnostic criteria for incomplete precocious puberty (isolated premature thelarche) in *Expert Consensus on the Diagnosis and Treatment of Central Precocious Puberty (2022)* and *Modern Pediatrics Diagnosis and Treatment*, the following requirements must be met: (1) Female children with initial symptoms of unilateral or bilateral breast development, without other signs of sexual development; (2) No accelerated growth and bone age not exceeding the actual age by 1 year; (3) No vaginal bleeding; (4) Plasma estradiol (E2) and follicle-stimulating hormone (FSH) levels within the reference range or slightly elevated.
• 2. Based on the doctor's clinical judgment, the traditional Chinese medicine (TCM) syndrome type conforms to the diagnostic criteria for phlegm-dampness internal accumulation syndrome. With reference to the syndrome classification criteria in *Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Pediatric Precocious Puberty (2023 Edition)*, the diagnosis can be made if the child meets 2-3 or more symptoms of any syndrome type, and the tongue and pulse conditions are basically consistent with the syndrome. Details of the syndrome are as follows: Phlegm-dampness internal accumulation: The child has premature appearance of secondary sexual characteristics, which may be accompanied by excessive consumption of fatty and sweet foods, obesity, heavy sensation in limbs, being quiet and inactive, sticky sensation in the mouth, red tongue with thick and greasy coating, and slippery and rapid pulse.
• 3. Obtain the informed consent form signed by the legal guardian of the subject.

Exclusion Criteria

• 1. Children with peripheral precocious puberty or central precocious puberty (idiopathic and secondary);
• 2. Children with other severe underlying diseases, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolic system, and skeletal system;
• 3. Those allergic to any component of Qingwei Huazhuo Recipe (Product: Jinsaiyu);
• 4. Those currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months;
• 5. Children judged by researchers to have poor compliance and are not suitable for entering this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
breast nucleus diameter	The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.	Measured by the attending physician using a straightedge

Secondary Outcome Measures

Name	Time	Method
Bone age	The measurement times are before the start of the experiment and the 24th week after the start.	Bone age is determined by radiologists in our hospital who take a posteroanterior radiograph of the left hand and judge the bone age according to the Greulich-Pyle (GP) atlas method.
Traditional Chinese Medicine syndrome score	The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.	Based on the \*Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Pediatric Precocious Puberty (2023 Edition)\* and clinical experience, the Traditional Chinese Medicine (TCM) syndrome scores were screened and determined.