Actively Recruiting

Phase 4
Age: 8Years - 9Years
FEMALE
NCT06820931

Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty

Led by Children's Hospital of Fudan University · Updated on 2025-02-11

80

Participants Needed

1

Research Sites

60 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

1\. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. Assess the therapeutic effect of nourishing yin and purging fire traditional Chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional Chinese medicine

CONDITIONS

Official Title

Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty

Who Can Participate

Age: 8Years - 9Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Girls aged over 8 years and up to 9 years
  • Breast bud Tanner stage II with breast bud diameter less than 3 cm
  • Ultrasound showing unilateral ovarian volume between 1 and 3 ml and/or follicle diameter of 4 mm or more
  • Bone age not exceeding actual age by more than 1 year
  • LHRH stimulation test with LH/FSH ratio less than or equal to 0.6 and LH peak less than or equal to 5.0 IU/L
  • Good compliance with study procedures
  • Patients and parents willing to actively cooperate with the clinical trial
  • Legal guardian has signed the informed consent form
Not Eligible

You will not qualify if you...

  • Disorders of gonadal development such as chromosomal abnormalities, hypospadias, or intersex conditions
  • Use of treatments affecting gonadal function, including chemotherapy or radiotherapy
  • Diabetes, thyroid dysfunction, obesity, lipid metabolism disorders, or other congenital diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China, 201102

Actively Recruiting

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Research Team

W

Wen Sun

CONTACT

T

Teng Fan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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