Idiopathic Precocious Puberty
Conditions
Keywords
Idiopathic Precocious Puberty, Rapid Progressive, Integrative Chinese and Western Medicine, Evidence-based Medicine
Brief summary
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.
Detailed description
In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.
Interventions
DRUGZiyinxiehuo Granules Herbs
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
DRUGMegestrol Acetate Tablet
the dose is 6-8mg/d, three times per day after meals.
Usage： 80μg/kg by subcutaneous injection, every 4 weeks
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
5 Years to 8 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of the Mammary Nucleus Diameter reduced to less than 1cm | After six months of continuous treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ratio of bone age difference to chronological age difference | After six months of continuous treatment | 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. |
Countries
China
Outcome results
None listed