Clinical trial
Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Name
18401902300
Description
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.
Trial arms
Trial start
2019-08-15
Estimated PCD
2022-08-15
Trial end
2022-09-30
Status
Completed
Phase
Early phase I
Treatment
Ziyinxiehuo Granules Herbs
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Arms:
Ziyinxiehuo Granules and Megestrol Acetate
Other names:
nourishing"Yin"-removing"Fire" Granules
Megestrol Acetate Tablet
the dose is 6-8mg/d, three times per day after meals.
Arms:
Ziyinxiehuo Granules and Megestrol Acetate
Leuprorelin Acetate 3.75mg Injection
Usage： 80μg/kg by subcutaneous injection, every 4 weeks
Arms:
Gonadotrophin
Size
126
Primary endpoint
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
After six months of continuous treatment
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 126, 'type': 'ACTUAL'}}
Updated at
2024-02-07
1 organization
Organization
Children's Hospital of Fudan University