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出境医 / 临床实验 / Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

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

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.

Condition or disease Intervention/treatment Phase
Idiopathic Precocious Puberty Drug: Ziyinxiehuo Granules Herbs Drug: Megestrol Acetate Tablet Drug: Leuprorelin Acetate 3.75mg Injection Phase 4

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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 164 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021
Arms and Interventions
Arm Intervention/treatment
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.
 Drug: Ziyinxiehuo Granules Herbs
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Other Name: nourishing"Yin"-removing"Fire" Granules

Drug: Megestrol Acetate Tablet
the dose is 6-8mg/d, three times per day after meals.
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.
 Drug: Leuprorelin Acetate 3.75mg Injection
Usage： 80μg/kg by subcutaneous injection, every 4 weeks
Outcome Measures
Primary Outcome Measures :
  1. Percentage of the Mammary Nucleus Diameter reduced to less than 1cm [ Time Frame: After six months of continuous treatment ]
    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 :
  1. Ratio of bone age difference to chronological age difference [ Time Frame: After six months of continuous treatment ]
    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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   5 Years to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Jian Yu, professor 021-64931219 Yuj@shmu.edu.cn
Contact: Yonghong Wang, professor 021-64931219 wyhekyy@126.com

Locations
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China, Shanghai
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Jian Yu, Doctor    021-64931219    yuj@shmu.edu.cn   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
Layout table for investigator information
Study Chair: Jian Yu Children's Hospital of Fudan University
Tracking Information
First Submitted Date  ICMJE May 22, 2019
First Posted Date  ICMJE May 28, 2019
Last Update Posted Date January 13, 2020
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Percentage of the Mammary Nucleus Diameter reduced to less than 1cm [ Time Frame: After six months of continuous treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2020) 		Ratio of bone age difference to chronological age difference [ Time Frame: After six months of continuous treatment ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019) 		Ratio of bone age difference to chronological age difference [ Time Frame: After six months of continuous treatment ]
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, and the bone age will be measured according to the Greulich-Pyle map method. Ratio of bone age difference to chronological age will be the result that the difference between the bone age before and after treatment will be divided by the difference between the chronological age before and after treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Official Title  ICMJE Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Idiopathic Precocious Puberty
Intervention  ICMJE
  • Drug: Ziyinxiehuo Granules Herbs
    1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
    Other Name: nourishing"Yin"-removing"Fire" Granules
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Ziyinxiehuo Granules Herbs
    • Drug: Megestrol Acetate Tablet
  • 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.
    Intervention: Drug: Leuprorelin Acetate 3.75mg Injection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 22, 2019) 		164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 5 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jian Yu, professor 021-64931219 Yuj@shmu.edu.cn
Contact: Yonghong Wang, professor 021-64931219 wyhekyy@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03963752
Other Study ID Numbers  ICMJE 18401902300
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jian Yu, Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jian Yu Children's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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