Partial precocious puberty (simple premature breast development)
Conditions
Interventions
Group A:Dabuyin Pills (concentrated pills) were taken first for 3 months, followed by placebo pills for 3 months
Group B:Placebo was given for 3 months, followed by Dabuyin Pills (concentrated pills) for 3 months
Sponsors
Children's Hospital of Fudan University
Eligibility
Sex/Gender
Female
Age
2 Years to 7.5 Years
Inclusion criteria
Inclusion criteria: 1: Girls aged 2 to 7.5 years (including 2 and 7.5 years) ; 2: Referring to the diagnostic criteria for incomplete precocious puberty (simple breast early development) in Expert Consensus on Diagnosis and Treatment of Central Precocious Puberty (2022) and Modern Pediatrics Diagnosis and Treatment, the following requirements are met: ? The first symptom was a girl with unilateral or bilateral mastectomy, without other signs of sexual development, ? no growth acceleration and premature bone development, ? no vaginal bleeding, ? plasma estradiol (E2) and follicle stimulating hormone (FSH) levels within the reference range or slightly increased; 3: Obtain informed consent signed by the subject's legal guardian.
Exclusion criteria
Exclusion criteria: 1: Children with peripheral precocious puberty, central precocious puberty (idiopathic and secondary) 2: Suffering from other serious underlying diseases, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism and bone system 3: Allergic to any component of Dabuyin pills (concentrated pills) 4: Children who had participated or were participating in other clinical trials within 1 month prior to enrollment 5: Children who used Dabuyin Polls or similar Chinese medicine within 1 month before enrollment 6: The investigator judged that the compliance was poor and the children were not suitable for entering the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nuclear index, uterine and ovarian volume, and maximum follicle diameter combined efficacy score; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum hormone level;bone age;Tanner level ;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactJian yu
Children's Hospital of Fudan University
Outcome results
None listed