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

NCT03963752 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2024-02-07

No results posted yet for this study

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.

Conditions

  • Idiopathic Precocious Puberty

Interventions

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

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Jian Yu, professor · Children's Hospital of Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-15
Primary Completion
2022-08-15
Completion
2022-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03963752 on ClinicalTrials.gov