Actively Recruiting
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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying girls aged 8 to 9 years with early puberty to understand differences in certain hormone levels, specifically AMH and SHBG, before and after diagnosis of rapid versus slow progression types. They aim to see if these hormone differences can predict rapid progression and to assess the effects of a traditional Chinese medicine treatment focused on nourishing yin and reducing fire. This study is a Phase 4 clinical trial conducted by the Children's Hospital of Fudan University. Participants are randomly assigned to one of two groups: a control group that receives no treatment, and an intervention group that takes the hospital-prepared Xuandi Ziyin Mixture. This mixture is a drug treatment given in doses of 30 ml three times daily for six months. The study uses triple masking to reduce bias during the evaluation period. Throughout the trial, researchers monitor hormone levels and the incidence of rapid puberty progression from enrollment through six months after treatment. Participants will undergo ultrasound exams, bone age assessments, and LHRH stimulation tests to track changes. Compliance and cooperation with study procedures are important, and informed consent is required from legal guardians for participation.
CONDITIONS
Brief 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
Eligibility Criteria
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 more than 1 year older than actual age
- LHRH stimulation test showing LH/FSH ratio not exceeding 0.6 and LH peak at least 5.0 IU/L
- Good compliance with study procedures
- Willingness of patient and parents to cooperate actively with the clinical trial
- Legal guardian has signed informed consent form
You will not qualify if you...
- Disorders of gonadal development, including chromosomal abnormalities, hypospadias, or intersex conditions
- Use of treatments affecting gonadal function, such as chemotherapy or radiotherapy
- Presence of 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants in the intervention group receive Xuandi Ziyin Mixture drug therapy, while the control group does not receive any intervention.
Regular visits for treatment and assessments during the 6-month period
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
W
Wen Sun
T
Teng Fan
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
Frequently Asked Questions
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