Clinical Study of Traditional Chinese Medicine in the Treatment of Phlegm-dampness Intrinsic Precocious Puberty (SHJG-PP)
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.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Jian Yu, PhD
- Telefonnummer: +86 13816881206
- E-post: yuj@shmu.edu.cn
Studieorter
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Fujian
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Xiamen, Fujian, Kina
- Xiamen Children's Hospital
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Kontakt:
- Fuchun Wang
- Telefonnummer: +86 13945319354
- E-post: 362440274@qq.com
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Guangdong
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Guangzhou, Guangdong, Kina, 510405
- The First Affiliated Hospital of Guangzhou University of Chinese Medicine
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Kontakt:
- Hua Liu
- Telefonnummer: +86 13672484231
- E-post: liuhua0321@126.com
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Henan
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Zhengzhou, Henan, Kina, 450000
- The First Affiliated Hospital of Henan University of Chinese Medicine
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Kontakt:
- Hong Zheng
- Telefonnummer: +86 18937153029
- E-post: drzhenghs@126.com
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Shandong
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Jinan, Shandong, Kina, 250011
- Affiliated Hospital of Shandong University of TCM
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Kontakt:
- Guiju Zhang
- Telefonnummer: +86 13685316296
- E-post: 13685316296@163.com
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Kina, 210102
- Children's Hospital of Fudan University
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Kontakt:
- Jian Yu
- Telefonnummer: +86 13816881206
- E-post: yuj@shmu.edu.cn
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Kontakt:
- Wenqin Wang
- Telefonnummer: +86 15001741617
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Sanghe Jianghuo Granules
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.
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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.
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|
Placebo-jämförare: Placebo
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.
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10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules.
Administration: Oral, twice daily.
Duration: 3 consecutive months.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Breast Nodule Regression Rate
Tidsram: 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).
|
Baseline (Day 0) and Week 12
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Uterine Volume
Tidsram: Baseline (Day 0) and Week 12
|
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).
|
Baseline (Day 0) and Week 12
|
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Ovarian Volume
Tidsram: Baseline (Day 0) and Week 12
|
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).
|
Baseline (Day 0) and Week 12
|
|
Follicle Diameter
Tidsram: Baseline (Day 0) and Week 12
|
Maximum follicle diameter measured by transabdominal ultrasound, reported in millimeters (mm).
|
Baseline (Day 0) and Week 12
|
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Serum Luteinizing Hormone (LH)
Tidsram: Baseline (Day 0) and Week 12
|
Serum LH level measured by chemiluminescent immunoassay, reported in U/L.
Blood samples are collected in the morning after an overnight fast.
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Baseline (Day 0) and Week 12
|
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Serum Follicle-Stimulating Hormone (FSH)
Tidsram: Baseline (Day 0) and Week 12
|
Serum FSH level measured by chemiluminescent immunoassay, reported in U/L.
Blood samples are collected in the morning after an overnight fast.
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Baseline (Day 0) and Week 12
|
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Traditional Chinese Medicine (TCM) Syndrome Score
Tidsram: Baseline (Day 0), Week 4, Week 8, and Week 12
|
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.
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Baseline (Day 0), Week 4, Week 8, and Week 12
|
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Body Mass Index (BMI)
Tidsram: Baseline (Day 0) and Week 12
|
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).
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Baseline (Day 0) and Week 12
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Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
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