Herbal brew for early puberty? trial ends early
NCT ID NCT07141615
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a traditional Chinese herbal formula called Qingwei Huazhuo Decoction in 94 girls with mild early puberty (breast development starting too soon). The goal was to see if the herbs could slow breast growth and bone age. However, the trial was terminated early, so we don't have clear results on whether it worked.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Qingwei Huazhuo Decoction (a blend of mulberry leaf, lotus leaf, malt, hawthorn, Poria cocos, gardenia, tangerine peel, licorice, and monk fruit powders)
- What this could lead to
- If it had worked, this herbal formula might have offered a natural option to slow early breast development in girls with mild precocious puberty.
- What could go wrong
- The trial was terminated early, so results are limited. It was a small, single-center study with no placebo group, making it hard to know if the herbs truly helped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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94 people
The number who actually took part.
- Started
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Mar 2026
- Finished
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Apr 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 8 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Children's Hospital of Fudan University
Shanghai, 201102, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.