Herbal granules aim to slow early puberty in young girls
NCT ID NCT07637019
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether Sanghe Jianghuo Granules, a traditional Chinese herbal medicine, can safely slow down early puberty in girls aged 5 to 8.5 years. The trial will involve 200 participants who will take the granules or a placebo twice daily for 3 months. The main goal is to see if breast development regresses, with secondary checks on hormone levels and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sanghe Jianghuo Granules (a traditional Chinese medicine blend of mulberry leaf, lotus leaf, rehmannia, anemarrhena, skullcap, and other herbs)
- What this could lead to
- If it works, this could offer a natural alternative to standard hormone therapy for early puberty, potentially with fewer side effects.
- What could go wrong
- This is an early-stage trial with only 200 participants, so results may not apply to all. The placebo group gets 10% active ingredient, which could blur the true effect. Also, the treatment is based on traditional Chinese medicine concepts, which may not be accepted globally.
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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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- 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 9 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. Female, aged between 5 and 9 years (inclusive). 2. Presence of secondary sexual characteristics before 8 years of age, consistent with simple premature thelarche / initial central precocious puberty (CPP) / Tanner stage II. 3. Traditional Chinese Medicine (TCM) syndrome differentiation: Phlegm-dampness internal accumulation syndrome. 4. Body mass index (BMI) greater than the 50th percentile for same age and sex. 5. Initial case, no prior medication for precocious puberty (including but not limited to GnRHa, sex hormones, growth hormones, Zhibai Dihuang Wan, Dabuyin Wan, or traditional Chinese weight-loss medicines) within the last 3 months. 6. Informed consent signed by the legal guardian(s), with ability to comply with the follow-up schedule. Exclusion Criteria: 1. Secondary precocious puberty due to central nervous system organic lesions, thyroid or adrenal disorders, ovarian tumors, or other underlying conditions. 2. Severe hepatic or renal dysfunction, or hematological diseases. 3. Use of sex hormones, growth hormones, Zhibai Dihuang Wan, Dabuyin Wan, or traditional Chinese weight-loss medicines within the last 3 months. 4. Inability to cooperate with examinations or poor compliance with follow-up visits (e.g., inability to complete ultrasound, blood collection, or scheduled visits).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, 250011, China
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Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 210102, China
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The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405, China
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The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000, China
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Xiamen Children's Hospital
Xiamen, Fujian, China
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