Clinical Study of Traditional Chinese Medicine in the Treatment of Phlegm-dampness Intrinsic Precocious Puberty

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Sanghe Jianghuo Granules
  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.
• Комбинированный продукт Placebo
  10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules. Administration: Oral, twice daily. Duration: 3 consecutive months.

Первичные конечные точки

• Breast Nodule Regression Rate [Срок оценки: Baseline (Day 0) and Week 12]

Вторичные конечные точки (7)

• Uterine Volume [Срок оценки: Baseline (Day 0) and Week 12]
• Ovarian Volume [Срок оценки: Baseline (Day 0) and Week 12]
• Follicle Diameter [Срок оценки: Baseline (Day 0) and Week 12]
• Serum Luteinizing Hormone (LH) [Срок оценки: Baseline (Day 0) and Week 12]
• Serum Follicle-Stimulating Hormone (FSH) [Срок оценки: Baseline (Day 0) and Week 12]
• Traditional Chinese Medicine (TCM) Syndrome Score [Срок оценки: Baseline (Day 0), Week 4, Week 8, and Week 12]
• Body Mass Index (BMI) [Срок оценки: Baseline (Day 0) and Week 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 5 центров

• Xiamen Children's Hospital — Xiamen
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Гуанчжоу
• The First Affiliated Hospital of Henan University of Chinese Medicine — Чжэнчжоу
• Affiliated Hospital of Shandong University of TCM — Цзинань
• Children's Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07637019 · fdek-tcm 2026-Q2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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