Research of Integrated Traditional Chinese and Western Medicine on Precocious Puberty

NCT07325903 | Not Yet Recruiting Early Phase 1

• 1 other identifier: FDCH-ZY-2025402
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Puberty, Precocious

Keywords

precocious puberty; Sanghe Jianghuo Granules; RCT

Outcome Measures

Primary Outcomes (1)

• Breast Tanner Stages

  Measured by the attending physician

  The measurement times are before the start of the experiment and the 3rd month after the start

Secondary Outcomes (2)

• Bone age

  The measurement times are before the start of the experiment and the 3rd month after the start

• Traditional Chinese Medicine syndrome score

  The measurement times are before the start of the experiment and the 3rd month after the start

Other Outcomes (13)

• Testosterone

  The measurement times are before the start of the experiment and the 3rd month after the start

• PRL

  The measurement times are before the start of the experiment and the 3rd month after the start

• Estradiol

  The measurement times are before the start of the experiment and the 3rd month after the start

Study Arms (2)

Control group

PLACEBO COMPARATOR

10% drug-containing placebo, for a period of 3 months.

Combination Product: 10% drug-containing placebo, for a period of 3 months.

Intervention group

ACTIVE COMPARATOR

administered "Mulberry and Lotus Leaf Heat-Clearing Granules," with the following drug composition: mulberry leaves, lotus leaves, fresh rehmannia, anemarrhena, scutellaria, atractylodes, etc., for an intervention period of 3 months..

Drug: administered "Mulberry and Lotus Leaf Heat-Clearing Granules," with the following drug composition: mulberry leaves, lotus leaves, fresh rehmannia, anemarrhena, scutellaria, atractylodes, etc.

Interventions

10% drug-containing placebo, for a period of 3 months. COMBINATION_PRODUCT

10% drug-containing placebo, for a period of 3 months. The drug was Mulberry and Lotus Leaf Heat-Clearing Granules.

Control group

administered "Mulberry and Lotus Leaf Heat-Clearing Granules," with the following drug composition: mulberry leaves, lotus leaves, fresh rehmannia, anemarrhena, scutellaria, atractylodes, etc. DRUG

administered "Mulberry and Lotus Leaf Heat-Clearing Granules," with the following drug composition: mulberry leaves, lotus leaves, fresh rehmannia, anemarrhena, scutellaria, atractylodes, etc., for an intervention period of 3 months.

Intervention group

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Secondary precocious puberty, associated with diabetes, thyroid dysfunction, other endocrine disorders, and severe underlying conditions.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

Jian Yu, Doctor

CONTACT

8613816881206; yuj@shmu.edu.cn

Teng Fan

CONTACT

8619921314120; fanteng@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (1)