Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Clinical Study of Traditional Chinese Medicine in the Treatment of Phlegm-dampness Intrinsic Precocious Puberty (SHJG-PP)

4 czerwca 2026 zaktualizowane przez: Children's Hospital of Fudan University

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

200

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Jian Yu, PhD
  • Numer telefonu: +86 13816881206
  • E-mail: yuj@shmu.edu.cn

Lokalizacje studiów

  • Chiny
    • Fujian
      • Xiamen, Fujian, Chiny
        • Xiamen Children's Hospital
        • Kontakt:
    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510405
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Kontakt:
    • Henan
      • Zhengzhou, Henan, Chiny, 450000
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Kontakt:
    • Shandong
      • Jinan, Shandong, Chiny, 250011
        • Affiliated Hospital of Shandong University of TCM
        • Kontakt:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Chiny, 210102
        • Children's Hospital of Fudan University
        • Kontakt:
        • Kontakt:
          • Wenqin Wang
          • Numer telefonu: +86 15001741617

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dziecko

Akceptuje zdrowych ochotników

Nie

Opis

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).

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: 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.
Komparator placebo: 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.
Produkt złożony: Placebo
10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules. Administration: Oral, twice daily. Duration: 3 consecutive months.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Breast Nodule Regression Rate
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Uterine Volume
Ramy czasowe: 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
Ovarian Volume
Ramy czasowe: 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
Ramy czasowe: Baseline (Day 0) and Week 12
Maximum follicle diameter measured by transabdominal ultrasound, reported in millimeters (mm).
Baseline (Day 0) and Week 12
Serum Luteinizing Hormone (LH)
Ramy czasowe: 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.
Baseline (Day 0) and Week 12
Serum Follicle-Stimulating Hormone (FSH)
Ramy czasowe: 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.
Baseline (Day 0) and Week 12
Traditional Chinese Medicine (TCM) Syndrome Score
Ramy czasowe: 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.
Baseline (Day 0), Week 4, Week 8, and Week 12
Body Mass Index (BMI)
Ramy czasowe: 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).
Baseline (Day 0) and Week 12

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Children's Hospital of Fudan University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

30 marca 2028

Ukończenie studiów (Szacowany)

30 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

4 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

4 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • fdek-tcm 2026-Q2

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Badania kliniczne na Sanghe Jianghuo Granules

Wyszukaj podobne próby

Sponsorzy i współpracownicy

Warunki medyczne

Interwencje lekowe

CROs by country

CROs in Kazakhstan

Warunki

Rzadkie choroby

Interwencje lekowe

Suplementy diety

Sponsor / Współpracownicy

Lokalizacje

Subskrybuj