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

Last updated: February 5, 2024
Sponsor: Children's Hospital of Fudan University
Overall Status: Completed

Phase

4

Condition

N/A

Treatment

Ziyinxiehuo Granules Herbs

Leuprorelin Acetate 3.75mg Injection

Megestrol Acetate Tablet

Clinical Study ID

NCT03963752
18401902300
  • Ages 5-8
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Girls are diagnosed as Idiopathic central precocious puberty by GnRH (gonadotrophinreleasing hormone)Stimulation Test, and their age of onset ≤8 years;
  • Tanner stages of breast in female patients ≥ Tanner III stage,diameter of mammillarynucleus ≥ 3cm;
  • B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, thediameter of follicle≥4mm;
  • Bone age: compared the chronological age, the bone age is more than 1 year and thebone 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

Exclusion Criteria:

  • Precocious precocity caused by the central nervous system organic diseases;
  • Precocious precocity caused by congenital hypothyroidism, congenital adrenalhyperplasia, adrenal tumor and ovarian or testicular neoplasms as well asMcCune-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.

Study Design

Total Participants: 126
Treatment Group(s): 3
Primary Treatment: Ziyinxiehuo Granules Herbs
Phase: 4
Study Start date:
August 15, 2019
Estimated Completion Date:
September 30, 2022

Study 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.

Connect with a study center

  • Children's Hospital of Fudan University

    Shanghai, Shanghai 201102
    China

    Site Not Available

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