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

Primary Purpose

Idiopathic Precocious Puberty

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ziyinxiehuo Granules Herbs
Megestrol Acetate Tablet
Leuprorelin Acetate 3.75mg Injection
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Precocious Puberty focused on measuring Idiopathic Precocious Puberty, Rapid Progressive, Integrative Chinese and Western Medicine, Evidence-based Medicine

Eligibility Criteria

5 Years - 8 Years (Child)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ziyinxiehuo Granules and Megestrol Acetate

Gonadotrophin

Arm Description

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: 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.

Outcomes

Primary Outcome Measures

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

Ratio of bone age difference to chronological age difference
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.

Full Information

First Posted
May 22, 2019
Last Updated
July 28, 2021
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03963752
Brief Title
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Official Title
Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Precocious Puberty
Keywords
Idiopathic Precocious Puberty, Rapid Progressive, Integrative Chinese and Western Medicine, Evidence-based Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ziyinxiehuo Granules and Megestrol Acetate
Arm Type
Experimental
Arm Description
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.
Arm Title
Gonadotrophin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ziyinxiehuo Granules Herbs
Other Intervention Name(s)
nourishing"Yin"-removing"Fire" Granules
Intervention Description
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Intervention Type
Drug
Intervention Name(s)
Megestrol Acetate Tablet
Intervention Description
the dose is 6-8mg/d, three times per day after meals.
Intervention Type
Drug
Intervention Name(s)
Leuprorelin Acetate 3.75mg Injection
Intervention Description
Usage： 80μg/kg by subcutaneous injection, every 4 weeks
Primary Outcome Measure Information:
Title
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
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.
Time Frame
After six months of continuous treatment
Secondary Outcome Measure Information:
Title
Ratio of bone age difference to chronological age difference
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.
Time Frame
After six months of continuous treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Yu, professor
Phone
021-64931219
Email
Yuj@shmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghong Wang, professor
Phone
021-64931219
Email
wyhekyy@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Yu, professor
Organizational Affiliation
Children's Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian Yu, Doctor
Phone
021-64931219
Email
yuj@shmu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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

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