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Gonadorelin

GnRH, Luteinizing Hormone-Releasing Hormone, LHRH, Factrel

Quick Stats
Studies 192
Trials 100
Completed PHASE4 INTERVENTIONAL NCT03963752

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

View on ClinicalTrials.gov Updated Dec 15, 2025

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

Name: Ziyinxiehuo Granules Herbs
Type: DRUG
Description: 1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Name: Megestrol Acetate Tablet
Type: DRUG
Description: the dose is 6-8mg/d, three times per day after meals.
Name: Leuprorelin Acetate 3.75mg Injection
Type: DRUG
Description: Usage: 80μg/kg by subcutaneous injection, every 4 weeks

Primary Outcomes

Measure: Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
TimeFrame: After six months of continuous treatment
Description: 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.

Trial Information

NCT ID

NCT03963752

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE4

Sponsor

Children's Hospital of Fudan University

Last Updated

December 15, 2025