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

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

NCT07141615•Children's Hospital of Fudan University

View on ClinicalTrials.gov

Summary

Eligibility

Age

5 - 8 years

Sex

FEMALE

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.

Key Dates

Start Date

March 30, 2026

Primary Completion Date

November 16, 2027

Completion Date

December 16, 2027

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

Precocious Puberty

Interventions

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

COMBINATION_PRODUCT

diet and exercise education

BEHAVIORAL

Contacts

Wen Sun, Doctor

CONTACT

8613818844692 sunwenhere@163.com

Teng Fan

CONTACT

8619921314120 fantengcn@163.com

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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: March 19, 2026Data 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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Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type

Inclusion Criteria

Exclusion Criteria

A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty

A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)

A Study to Assess the Efficacy and Safety of the Triptorelin 6-month Formulation in Paediatric Participants With Central Precocious Puberty.

Diagnostic Power of Basal LH Compared to Peak LH After Stimulus Test in the Diagnosis of Central Precocious Puberty

Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP

Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty