Skip to content

Trial · Interventional

CompletedPhase 4Registry data

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

NCTNCT03963752 (opens ClinicalTrials.gov in a new tab)Other id18401902300
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
126 participants (actual)
Sponsor
Children's Hospital of Fudan University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
15 Aug 2019
Primary completion
15 Aug 2022
Completion
30 Sept 2022
First posted
28 May 2019
Last update posted
7 Feb 2024
Conditions
Idiopathic Precocious Puberty

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20192020202120222023
  1. Ph 4

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

    NCT03963752

    15 Aug 2019 to 30 Sept 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Ziyinxiehuo Granules HerbsDrug
  • Megestrol Acetate TabletDrug
  • Leuprorelin Acetate 3.75mg InjectionDrug

Arms2

  • Experimental

    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.

  • Active comparator

    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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage of the Mammary Nucleus Diameter reduced to less than 1cm

    Time frame · After six months of continuous treatment

    Registry 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.

Secondary outcomes(1)

  1. Ratio of bone age difference to chronological age difference

    Time frame · After six months of continuous treatment

    Registry description

    The left hand orthotopic X-ray (including the carpal bone and the lower end of the ulna) will be filmed by the Department of Radiology before and after treatment, and the bone age will be measured according to the Greulich-Pyle map method. Ratio of bone age difference to chronological age difference will be calculated.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 5 Years up to 8 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.