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

Fudan University

Status: Not yet enrolling

Conditions: Precocious Puberty

Treatments: Behavioral: diet and exercise education; Combination Product: Qingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor

Study type: Interventional

Funder types: Other

Identifiers

NCT07141615

FDCH-ZY-2025162

Details and patient eligibility

About

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

Enrollment: 94 estimated patients

Sex: Female

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups

Intervention group

Experimental group

Description:

The intervention group is administered Qingwei Huazhuo Decoction therapy and diet and exercise education for a period of six months.

Treatment:

Combination Product: Qingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor

Behavioral: diet and exercise education

Control group

Experimental group

Description:

diet and exercise education

Treatment:

Behavioral: diet and exercise education