central precocious puberty
Conditions
Interventions
Monotherapy with Western Medicine group:Leuprorelin was administered subcutaneously once every 28 days, at a dose of 3.75 mg each time, for a total of 6 months.
Integrated Chinese Medicine Group:In addition to the treatment with Western medicine alone, patients were given oral Dabuyin Pills, 3g each time, twice a day, taken with warm water, for 6 consecutive
Sponsors
Shanxi Provincial Children's Hospital (Shanxi Provincial Maternal and Child Health Hospital)
Eligibility
Sex/Gender
Female
Age
6 Years to 10 Years
Inclusion criteria
Inclusion criteria: 1. All patients were female, aged 6-10 years. 2. They met the diagnostic criteria for central precocious puberty according to the Western medicine expert consensus on the diagnosis and treatment of central precocious puberty (2022). 3. They met the diagnostic criteria for Yin deficiency and fire excess syndrome according to the traditional Chinese medicine guidelines for the integrated traditional Chinese and Western medicine diagnosis and treatment of precocious puberty in children (2023 edition). 4. They had not received any drug treatment for precocious puberty in the past 3 months. 5. The patients were eating normally, had good compliance, and could cooperate in completing treatment and examinations. 6. The patients' families were informed about the study and voluntarily signed informed consent forms. 7. They could tolerate leuprorelin and Dabu Yin Wan (a traditional Chinese medicine formula).
Exclusion criteria
Exclusion criteria: 1. Individuals who have received other targeted treatments for precocious puberty before enrollment; 2. Individuals with other endocrine disorders such as thyroid, adrenal, or pituitary diseases; 3. Individuals with benign or malignant tumors of the reproductive system, brain, or other organs; 4. Individuals with congenital genetic diseases or severe physical deformities; 5. Individuals allergic to any component of the study drug; 6. Individuals with severe dysfunction of vital organs such as the liver, kidneys, heart, or lungs; 7. Individuals with poor compliance who are unable to cooperate with follow-up and examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall clinical efficacy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone Age Index;Sex Hormone Levels;Secondary Sexual Characteristics;Traditional Chinese Medicine Syndrome Score;Adverse Reaction Rate; | — |
Countries
China
Contacts
Public ContactWang Lei
Shanxi Provincial Children's Hospital (Shanxi Provincial Maternal and Child Health Hospital)
Outcome results
None listed