Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Ziyinxiehuo Granules Herbs (Drug)
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.
干预措施: Megestrol Acetate Tablet (Drug)
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.
干预措施: Leuprorelin Acetate 3.75mg Injection (Drug)
结局指标
主要结局
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
时间窗: 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.
次要结局
- Ratio of bone age difference to chronological age difference(After six months of continuous treatment)
研究者
Jian Yu
Director of TCM Department
Children's Hospital of Fudan University