Clinical trial NCT03963752: Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Official title: Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Idiopathic Precocious Puberty
Keywords: Idiopathic Precocious Puberty
Rapid Progressive
Integrative Chinese and Western Medicine
Evidence-based Medicine
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2019-05-28
Enrollment: 126
Sex: FEMALE
Minimum age (years): 5
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
timeFrame: After six months of continuous treatment
Secondary outcomes:
measure: Ratio of bone age difference to chronological age difference
timeFrame: After six months of continuous treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children's Hospital of Fudan University
name: Jian Yu, professor
role: STUDY_CHAIR
References: