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

Overview

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.

Full Title of Study: “Evidence-based Medical Research on the Treatment of Children’s Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2021

Detailed Description

In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group A(82 cases)and Group B ( 82 cases). Patients in Group A are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group B received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Interventions

  • Drug: Ziyinxiehuo granules Herbs
    • Arm:Experimental: Group A Drug:Ziyinxiehuo granules Herbs .1 pack of Ziyinxiehuo granules Herbs includes shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g. Usage: administered after dissolved, 2 times per day after a meal .
  • Drug: Megestrol Acetate Tablet
    • Arm:Experimental: Group A Drug :Megestrol Acetate Tablet .Usage:the dose is 6-8mg/d, and the everyday total amount is taken orally in three times after a meal.
  • Drug: Leuprorelin Acetate 3.75mg Injection
    • Arm: Active Comparator: Group B Drug:Leuprorelinb Acetate Usage: 80μg/kg every time by subcutaneous injection, every 4 weeks for once.

Arms, Groups and Cohorts

  • Experimental: Group A
    • Experimental:Group A Intervention :Subjects in Group A 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 B
    • Active Comparator: Group B Intervention: Subjects in Group B 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 5 Years

Maximum Age: 8 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Children’s Hospital of Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jian Yu, Director of TCM Department – Children’s Hospital of Fudan University
  • Overall Official(s)
    • Jian Yu, Study Chair, Children’s Hospital of Fudan University
  • Overall Contact(s)
    • Jian Yu, professor, 021-64931219, Yuj@shmu.edu.cn

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