Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102, China
NCT Number: NCT03963752
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.
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Notify Me5 year–8 year
Female
Interventional
Phase 4
Shanghai, Shanghai Municipality, 201102, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Other names: nourishing"Yin"-removing"Fire" Granules
the dose is 6-8mg/d, three times per day after meals.
Usage: 80μg/kg by subcutaneous injection, every 4 weeks
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.
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.
Children's Hospital of Fudan University
Other
Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
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