Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With … (NCT07141615) | Clinical Trial Compass
TerminatedNot Applicable
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
Stopped: The study was terminated prematurely due to the inapplicability of the primary outcome measure
China94 participantsStarted 2026-03-30
Plain-language summary
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
Who can participate
Age range5 Years – 8 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 q…
What they're measuring
1
breast nucleus diameter
Timeframe: The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.