NCT03963752

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

Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2019-08-15
• Primary completion: 2022-08-15
• Completion: 2022-09-30
• First posted: 2019-05-28
• Last updated: 2024-02-07

Locations

1 site across 1 country: China