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

2026년 6월 4일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Jian Yu, PhD
  • 전화번호: +86 13816881206
  • 이메일: yuj@shmu.edu.cn

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 더블

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
위약 비교기: 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.
조합 제품: Placebo
10% active-component placebo, matching the appearance, taste, and packaging of Sanghe Jianghuo Granules. Administration: Oral, twice daily. Duration: 3 consecutive months.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Breast Nodule Regression Rate
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Uterine Volume
기간: 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
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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)
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Children's Hospital of Fudan University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2028년 3월 30일

연구 완료 (추정된)

2028년 6월 30일

연구 등록 날짜

최초 제출

2026년 6월 4일

QC 기준을 충족하는 최초 제출

2026년 6월 4일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 4일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • fdek-tcm 2026-Q2

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

Sanghe Jianghuo Granules에 대한 임상 시험

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약물 개입

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스폰서 / 협력자

위치

구독하다