Idiopathic Precocious Puberty Clinical Trial
Official title:
Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
| Verified date | February 2024 |
| Source | Children's Hospital of Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.
| Status | Completed |
| Enrollment | 126 |
| Est. completion date | September 30, 2022 |
| Est. primary completion date | August 15, 2022 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 5 Years to 8 Years |
| Eligibility | Inclusion Criteria: - Girls are diagnosed as Idiopathic central precocious puberty by GnRH (gonadotrophin releasing hormone)Stimulation Test, and their age of onset =8 years; - Tanner stages of breast in female patients = Tanner III stage,diameter of mammillary nucleus = 3cm; - B-type ultrasonography: the volume of uterus=3ml, the volume of ovary=1.5ml, the diameter of follicle=4mm; - Bone age: compared the chronological age, the bone age is more than 1 year and the bone age <11.5 years old; - It progresses rapidly, ratio of bone age difference to chronological age difference> 1; - No GnRH analogs or sex hormones were administrated in the past; - All above are needed at the same time. Exclusion Criteria: - Precocious precocity caused by the central nervous system organic diseases; - Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc; - Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous; - Pseudo sexual precocity and partial precocious puberty. |
| Country | Name | City | State |
|---|---|---|---|
| China | Children's Hospital of Fudan University | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Children's Hospital of Fudan University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of the Mammary Nucleus Diameter reduced to less than 1cm | The investigators will measure subjects' mammary nucleus diameter through the midline of the breast with a ruler after six months of continuous treatment, and percentage of the mammary nucleus diameter reduced to less than 1cm in each group will be calculated. | After six months of continuous treatment | |
| Secondary | Ratio of bone age difference to chronological age difference | The left hand orthotopic X-ray (including the carpal bone and the lower end of the ulna) will be filmed by the Department of Radiology before and after treatment, and the bone age will be measured according to the Greulich-Pyle map method. Ratio of bone age difference to chronological age difference will be calculated. | After six months of continuous treatment |