Clinical trial NCT06820931: Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Official title: Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Puberty Changes
Keywords: TCM
puberty
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 8
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

* Girls with an onset age \>8 years and ≤9 years;
* Breast bud Tanner stage II breast bud diameter \<3 cm;
* Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm;
* Bone age does not exceed actual age by more than 1 year;
* LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L.
* Good compliance;
* Patients and their parents are willing to actively cooperate with the clinical trial;
* Legal guardian signs the informed consent form.

Exclusion Criteria:

* Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.;
* Use of treatments that affect gonadal function such as chemotherapy radiotherapy;
* Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.

Primary outcomes:
measure: The incidence of rapid progression type of precocious puberty
timeFrame: From enrollment to 6 months after treatment.
Secondary outcomes:
measure: AMH
timeFrame: From enrollment to 6 months after treatment.
measure: SHBG
timeFrame: From enrollment to 6 months after treatment.
Other outcomes:
measure: Height
timeFrame: From enrollment to 6 months after treatment.
measure: Weight
timeFrame: From enrollment to 6 months after treatment.
measure: Bone age
timeFrame: From enrollment to 6 months after treatment.
measure: LH
timeFrame: From enrollment to 6 months after treatment.
measure: FSH
timeFrame: From enrollment to 6 months after treatment.
measure: Estradiol
timeFrame: From enrollment to 6 months after treatment.
measure: Testosterone
timeFrame: From enrollment to 6 months after treatment.
measure: PRL
timeFrame: From enrollment to 6 months after treatment.
measure: Traditional Chinese Medicine syndrome score
timeFrame: From enrollment to 6 months after treatment.
measure: Breast Tanner staging
timeFrame: From enrollment to 6 months after treatment.
measure: Uterine volume
timeFrame: From enrollment to 6 months after treatment.
measure: ovarian volume
timeFrame: From enrollment to 6 months after treatment.
measure: follicle diameter
timeFrame: From enrollment to 6 months after treatment.
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
References: