Precocious PubertySHJG-PPNCT07637019
Clinical Study of Traditional Chinese Medicine in the Treatment of Phlegm-dampness Intrinsic Precocious Puberty
A study testing Sanghe Jianghuo Granules in people with Precocious Puberty, run by Children's Hospital of Fudan University at 5 sites in China.
Trial summary
Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance. In China, the incidence of precocious puberty has been increasing year by year. Read more about this study
- Who is it for?
- Ages 5 to 9 years, women only
- Conditions the study is for
- Precocious Puberty
- What is being tested?
- Sanghe Jianghuo Granules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 9 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Female, aged between 5 and 9 years (inclusive).
- Presence of secondary sexual characteristics before 8 years of age, consistent with simple premature thelarche / initial central precocious puberty (CPP) / Tanner stage II.
- Traditional Chinese Medicine (TCM) syndrome differentiation: Phlegm-dampness internal accumulation syndrome.
- Body mass index (BMI) greater than the 50th percentile for same age and sex.
- 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.
- Informed consent signed by the legal guardian(s), with ability to comply with the follow-up schedule.
Who cannot join
- Secondary precocious puberty due to central nervous system organic lesions, thyroid or adrenal disorders, ovarian tumors, or other underlying conditions.
- Severe hepatic or renal dysfunction, or hematological diseases.
- Use of sex hormones, growth hormones, Zhibai Dihuang Wan, Dabuyin Wan, or traditional Chinese weight-loss medicines within the last 3 months.
- Inability to cooperate with examinations or poor compliance with follow-up visits (e.g., inability to complete ultrasound, blood collection, or scheduled visits).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
Hua Liu, +86 13672484231, liuhua0321@126.com
Affiliated Hospital of Shandong University of TCM
Jinan, Shandong, 250011
Guiju Zhang, +86 13685316296, 13685316296@163.com
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 210102
Jian Yu, +86 13816881206, yuj@shmu.edu.cn
Wenqin Wang, +86 15001741617
Xiamen Children's Hospital
Xiamen, Fujian
Fuchun Wang, +86 13945319354, 362440274@qq.com
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
Hong Zheng, +86 18937153029, drzhenghs@126.com
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Sanghe Jianghuo Granules in the Treatment of Girls Aged 5-8.5 Years With Precocious Puberty and Phlegm-Dampness Internal Accumulation Syndrome According to Traditional Chinese Medicine
Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance. In China, the incidence of precocious puberty has been increasing year by year. Precocious puberty exerts long-term and systemic impacts on children's health: advanced bone age leads to short stature; earlier sexual development than peers may induce emotional problems such as anxiety and inferiority; it may increase the risk of obesity and type 2 diabetes, posing long-term hazards to cardiovascular health; it may also result in irregular menstruation or dysmenorrhea, exerting indirect effects on reproductive health.
Modern traditional Chinese medicine (TCM) holds that: various factors lead to liver-kidney yin deficiency, hyperactivity of ministerial fire, and early arrival of tian gui (the substance responsible for promoting growth, development and reproduction), thereby triggering premature sexual development. The main syndrome types identified in clinical practice include yin deficiency with fire hyperactivity syndrome, liver stagnation transforming into fire syndrome, and phlegm-dampness internal accumulation syndrome.
Read more
Since the late 1970s, the investigators' department has taken the lead in treating precocious puberty with TCM diagnostic methods, proposing that the pathogenesis of precocious puberty lies in "kidney yin deficiency and hyperactivity of ministerial fire", and adopting the therapy of nourishing yin and purging fire for its treatment. A number of studies have confirmed that TCM medicines with the effects of nourishing yin and purging fire can effectively alleviate the yin deficiency with fire hyperactivity syndrome in children, delay the development of secondary sexual characteristics and bone age.
At present, central precocious puberty is mostly treated with gonadotropin-releasing hormone analogs (GnRHa). However, this treatment has the drawback of inhibiting the growth axis, yielding limited benefits for children with advanced bone age, overweight or obesity, and may even affect glucose and lipid metabolism. Moreover, some children with precocious puberty complicated with obesity may be intolerant to this therapy. In contrast, TCM therapy and integrated TCM-Western medicine therapy can effectively delay the development of secondary sexual characteristics and advanced bone age, and improve final adult height, thus being widely applied in China.
Although a large number of relevant studies have been reported in recent years and TCM diagnosis and treatment guidelines for precocious puberty have been formulated, there is still a lack of high-quality evidence-based medical research to support the advantageous aspects of integrated TCM-Western medicine diagnosis and treatment. Additionally, the underlying mechanisms of diagnosis and treatment for different syndrome types of precocious puberty remain insufficiently studied.
In this study, the investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of Sanghe Jianghuo Granules on the regulation of the hypothalamic-pituitary-gonadal (HPG) axis, metabolic homeostasis and inflammatory microenvironment, so as to verify its efficacy and safety. Furthermore, combined with transcriptomics, proteomics and network pharmacology, the investigators will identify the key targets and action pathways of Sanghe Jianghuo Granules, and verify its regulatory effect on the HPG axis through in vivo and in vitro experiments.
- Conditions
- Precocious Puberty
- Being tested
- Sanghe Jianghuo Granules, Placebo
- Keywords
- Precocious Puberty, Sanghe Jianghuo Granules, Traditional Chinese Medicine, Phlegm-Dampness Syndrome
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanghe Jianghuo GranulesDrug
Composition: Mori Folium (Sang Ye), Nelumbinis Folium (He Ye), Rehmanniae Radix (Sheng Di), Anemarrhenae Rhizoma (Zhi Mu), Scutellariae Radix (Huang Qin), Atractylodis Macrocephalae Rhizoma (Bai Zhu), and other ingredients. Formulation: Granules. Administration: Oral, twice daily. Dosage: Based on body weight. Duration: 3 consecutive months.
PlaceboCombination product
10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules. Administration: Oral, twice daily. Duration: 3 consecutive months.
| Study group | Role | What they receive |
|---|---|---|
| Sanghe Jianghuo Granules | Experimental | Participants receive Sanghe Jianghuo Granules orally, twice daily (dosage based on body weight), for 3 consecutive months. All participants also receive standardized lifestyle guidance for precocious puberty. Receives: Drug: Sanghe Jianghuo Granules |
| Placebo | Placebo comparator | Participants receive placebo (10% active-component, matching appearance, taste, and packaging of Sanghe Jianghuo Granules) orally, twice daily, for 3 consecutive months. All participants also receive standardized lifestyle guidance for precocious puberty. Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Nodule Regression Rate
Percentage reduction in breast nodule diameter at Week 12 compared to baseline, calculated as (baseline diameter - Week 12 diameter) / baseline diameter × 100%. Breast nodule diameter is measured by physical examination (palpation and/or ultrasound).
Measured: Baseline (Day 0) and Week 12
Secondary outcomes (7)
Uterine Volume
Uterine volume measured by transabdominal ultrasound. Volume is calculated using the formula: V = (π/6) × length × anteroposterior diameter × transverse diameter, reported in cubic centimeters (cm³).
Measured: Baseline (Day 0) and Week 12
Ovarian Volume
Ovarian volume measured by transabdominal ultrasound. Volume is calculated using the formula: V = (π/6) × length × anteroposterior diameter × transverse diameter, reported in cubic centimeters (cm³).
Measured: Baseline (Day 0) and Week 12
Follicle Diameter
Maximum follicle diameter measured by transabdominal ultrasound, reported in millimeters (mm).
Measured: Baseline (Day 0) and Week 12
Serum Luteinizing Hormone (LH)
Serum LH level measured by chemiluminescent immunoassay, reported in U/L. Blood samples are collected in the morning after an overnight fast.
Measured: Baseline (Day 0) and Week 12
Serum Follicle-Stimulating Hormone (FSH)
Serum FSH level measured by chemiluminescent immunoassay, reported in U/L. Blood samples are collected in the morning after an overnight fast.
Measured: Baseline (Day 0) and Week 12
Traditional Chinese Medicine (TCM) Syndrome Score
TCM syndrome score assessed based on clinical evaluation of key symptoms including: preference for meat over vegetables, hyperactivity/restlessness, and greasy tongue coating. Higher scores indicate more severe syndrome manifestations.
Measured: Baseline (Day 0), Week 4, Week 8, and Week 12
Body Mass Index (BMI)
BMI calculated as weight (kg) divided by height squared (m²). Weight is measured using an electronic scale (kg, accurate to 0.1 kg). Height is measured using a mechanical height measuring device (cm, accurate to 0.1 cm).
Measured: Baseline (Day 0) and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious PubertyStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07637019
- Sponsor's protocol ID
- fdek-tcm 2026-Q2
- Acronym
- SHJG-PP
- Status last verified
- Jun 2026
- First submitted
- 4 Jun 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Sanghe Jianghuo Granules in the Treatment of Girls Aged 5-8.5 Years With Precocious Puberty and Phlegm-Dampness Internal Accumulation Syndrome According to Traditional Chinese Medicine
- ClinicalTrials.gov ID
- NCT07637019
- Acronym / sponsor ID
- SHJG-PP / fdek-tcm 2026-Q2
- Conditions
- Precocious Puberty
- Keywords
- Precocious Puberty, Sanghe Jianghuo Granules, Traditional Chinese Medicine, Phlegm-Dampness Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Precocious puberty is characterized by the premature appearance of secondary sexual characteristics. Globally, the timing of puberty onset in children has shown a certain tendency to advance. In China, the incidence of precocious puberty has been increasing year by year. Precocious puberty exerts long-term and systemic impacts on children's health: advanced bone age leads to short stature; earlier sexual development than peers may induce emotional problems such as anxiety and inferiority; it may increase the risk of obesity and type 2 diabetes, posing long-term hazards to cardiovascular health; it may also result in irregular menstruation or dysmenorrhea, exerting indirect effects on reproductive health.
Modern traditional Chinese medicine (TCM) holds that: various factors lead to liver-kidney yin deficiency, hyperactivity of ministerial fire, and early arrival of tian gui (the substance responsible for promoting growth, development and reproduction), thereby triggering premature sexual development. The main syndrome types identified in clinical practice include yin deficiency with fire hyperactivity syndrome, liver stagnation transforming into fire syndrome, and phlegm-dampness internal accumulation syndrome.
Since the late 1970s, the investigators' department has taken the lead in treating precocious puberty with TCM diagnostic methods, proposing that the pathogenesis of precocious puberty lies in "kidney yin deficiency and hyperactivity of ministerial fire", and adopting the therapy of nourishing yin and purging fire for its treatment. A number of studies have confirmed that TCM medicines with the effects of nourishing yin and purging fire can effectively alleviate the yin deficiency with fire hyperactivity syndrome in children, delay the development of secondary sexual characteristics and bone age.
At present, central precocious puberty is mostly treated with gonadotropin-releasing hormone analogs (GnRHa). However, this treatment has the drawback of inhibiting the growth axis, yielding limited benefits for children with advanced bone age, overweight or obesity, and may even affect glucose and lipid metabolism. Moreover, some children with precocious puberty complicated with obesity may be intolerant to this therapy. In contrast, TCM therapy and integrated TCM-Western medicine therapy can effectively delay the development of secondary sexual characteristics and advanced bone age, and improve final adult height, thus being widely applied in China.
Although a large number of relevant studies have been reported in recent years and TCM diagnosis and treatment guidelines for precocious puberty have been formulated, there is still a lack of high-quality evidence-based medical research to support the advantageous aspects of integrated TCM-Western medicine diagnosis and treatment. Additionally, the underlying mechanisms of diagnosis and treatment for different syndrome types of precocious puberty remain insufficiently studied.
In this study, the investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the effects of Sanghe Jianghuo Granules on the regulation of the hypothalamic-pituitary-gonadal (HPG) axis, metabolic homeostasis and inflammatory microenvironment, so as to verify its efficacy and safety. Furthermore, combined with transcriptomics, proteomics and network pharmacology, the investigators will identify the key targets and action pathways of Sanghe Jianghuo Granules, and verify its regulatory effect on the HPG axis through in vivo and in vitro experiments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sanghe Jianghuo Granules | Experimental | Drug: Sanghe Jianghuo GranulesParticipants receive Sanghe Jianghuo Granules orally, twice daily (dosage based on body weight), for 3 consecutive months. All participants also receive standardized lifestyle guidance for precocious puberty. |
| Placebo | Placebo comparator | Combination Product: PlaceboParticipants receive placebo (10% active-component, matching appearance, taste, and packaging of Sanghe Jianghuo Granules) orally, twice daily, for 3 consecutive months. All participants also receive standardized lifestyle guidance for precocious puberty. |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Female, aged between 5 and 9 years (inclusive).
- Presence of secondary sexual characteristics before 8 years of age, consistent with simple premature thelarche / initial central precocious puberty (CPP) / Tanner stage II.
- Traditional Chinese Medicine (TCM) syndrome differentiation: Phlegm-dampness internal accumulation syndrome.
- Body mass index (BMI) greater than the 50th percentile for same age and sex.
- 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.
Key exclusion criteria (4 listed)
- Secondary precocious puberty due to central nervous system organic lesions, thyroid or adrenal disorders, ovarian tumors, or other underlying conditions.
- Severe hepatic or renal dysfunction, or hematological diseases.
- Use of sex hormones, growth hormones, Zhibai Dihuang Wan, Dabuyin Wan, or traditional Chinese weight-loss medicines within the last 3 months.
- Inability to cooperate with examinations or poor compliance with follow-up visits (e.g., inability to complete ultrasound, blood collection, or scheduled visits).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sanghe Jianghuo GranulesComposition: Mori Folium (Sang Ye), Nelumbinis Folium (He Ye), Rehmanniae Radix (Sheng Di), Anemarrhenae Rhizoma (Zhi Mu), Scutellariae Radix (Huang Qin), Atractylodis Macrocephalae Rhizoma (Bai Zhu), and other ingredients. Formulation: Granules. Administration: Oral, twice daily. Dosage: Based on body weight. Duration: 3 consecutive months. | Drug | Sanghe Jianghuo Granules |
| Placebo10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules. Administration: Oral, twice daily. Duration: 3 consecutive months. | Combination product | Placebo |
Primary outcome
Breast Nodule Regression Rate
Time frame: Baseline (Day 0) and Week 12
Percentage reduction in breast nodule diameter at Week 12 compared to baseline, calculated as (baseline diameter - Week 12 diameter) / baseline diameter × 100%. Breast nodule diameter is measured by physical examination (palpation and/or ultrasound).
7 secondary outcomes
Uterine Volume
Time frame: Baseline (Day 0) and Week 12
Ovarian Volume
Time frame: Baseline (Day 0) and Week 12
Follicle Diameter
Time frame: Baseline (Day 0) and Week 12
Serum Luteinizing Hormone (LH)
Time frame: Baseline (Day 0) and Week 12
Serum Follicle-Stimulating Hormone (FSH)
Time frame: Baseline (Day 0) and Week 12
Traditional Chinese Medicine (TCM) Syndrome Score
Time frame: Baseline (Day 0), Week 4, Week 8, and Week 12
Body Mass Index (BMI)
Time frame: Baseline (Day 0) and Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
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Inherited Reproductive Disorders
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A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sanghe Jianghuo Granules in people with Precocious Puberty, run by Children's Hospital of Fudan University at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Yu, PhD (+86 13816881206, yuj@shmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Nodule Regression Rate (time frame: Baseline (Day 0) and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.