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

NCT ID: NCT03963752

Last Updated: 2024-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-15
• Study Completion Date: 2022-09-30

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.

Conditions

Idiopathic Precocious Puberty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ziyinxiehuo Granules and Megestrol Acetate

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.

Group Type: EXPERIMENTAL

Ziyinxiehuo Granules Herbs

Intervention Type: DRUG

1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.

Megestrol Acetate Tablet

Intervention Type: DRUG

the dose is 6-8mg/d, three times per day after meals.

Gonadotrophin

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.

Group Type: ACTIVE_COMPARATOR

Leuprorelin Acetate 3.75mg Injection

Intervention Type: DRUG

Usage： 80μg/kg by subcutaneous injection, every 4 weeks

Interventions

Ziyinxiehuo Granules Herbs

1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.

Intervention Type: DRUG

Megestrol Acetate Tablet

the dose is 6-8mg/d, three times per day after meals.

Intervention Type: DRUG

Leuprorelin Acetate 3.75mg Injection

Usage： 80μg/kg by subcutaneous injection, every 4 weeks

Intervention Type: DRUG

Other Intervention Names

nourishing"Yin"-removing"Fire" Granules

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.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Yu

Director of TCM Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Yu, professor

Role: STUDY_CHAIR

Children's Hospital of Fudan University

Locations

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

18401902300

Identifier Type: -

Identifier Source: org_study_id