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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
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
|Contact: Jian Yu, professor||021-64931219||Yuj@shmu.edu.cn|
|Contact: Yonghong Wang, email@example.com|
|Children's Hospital of Fudan University||Recruiting|
|Shanghai, Shanghai, China, 201102|
|Contact: Jian Yu, Doctor 021-64931219 firstname.lastname@example.org|
|Study Chair:||Jian Yu, professor||Children's Hospital of Fudan University|