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

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ClinicalTrials.gov Identifier: NCT03963752
Recruitment Status : Recruiting
First Posted : May 28, 2019
Last Update Posted : July 29, 2021
Sponsor:
Information provided by (Responsible Party):
Jian Yu, Children's Hospital of Fudan University

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.

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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


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




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.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963752


Contacts
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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
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Study Chair: Jian Yu, professor Children's Hospital of Fudan University
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Responsible Party: Jian Yu, Director of TCM Department, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03963752    
Other Study ID Numbers: 18401902300
First Posted: May 28, 2019    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jian Yu, Children's Hospital of Fudan University:
Idiopathic Precocious Puberty
Rapid Progressive
Integrative Chinese and Western Medicine
Evidence-based Medicine
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases
Megestrol
Megestrol Acetate
Leuprolide
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Fertility Agents, Female
Fertility Agents