Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Fudan University

Status and phase: Completed; Phase 4

Conditions: Idiopathic Precocious Puberty

Treatments: Drug: Leuprorelin Acetate 3.75mg Injection; Drug: Megestrol Acetate Tablet; Drug: Ziyinxiehuo Granules Herbs

Study type: Interventional

Funder types: Other

Identifiers

NCT03963752

18401902300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 5 to 8 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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126 participants in 2 patient groups

Ziyinxiehuo Granules and Megestrol Acetate

Experimental group

Description:

Experimental：Group Ziyinxiehuo Granules and Megestrol Acetate Tablet Intervention :Subjects in Group Ziyinxiehuo Granules and megestrol acetate tablet will be treated with Ziyinxiehuo Granules and megestrol acetate tablet for 6 months.1 pack of Ziyinxiehuo granules Herbs includes shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g. Ziyinxiehuo Granules is administered after dissolved,1pack every time, 2 times per day after a meal; and the dosage of megestrol acetate is 6-8mg/d, which is taken in 3 times after a meal.

Treatment:

Drug: Megestrol Acetate Tablet

Drug: Ziyinxiehuo Granules Herbs

Gonadotrophin

Active Comparator group

Description:

Active Comparator: Group Gonadotrophin Intervention: Subjects in Group Gonadotrophin will be treated with gonadotrophin releasing hormone agonist for 6months. In our study Leuprorelin Acetate 3.75mg Injection will be applied, the dosage of which is 80μg/kg every time by subcutaneous injection, every 4 weeks for once.

Treatment:

Drug: Leuprorelin Acetate 3.75mg Injection