Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Change in some index of B type ultrasonography ( uterus,ovary,follicle )
研究概览
简要总结
Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease.
详细描述
In the research, 138 precocious puberty children are randomly divided into the Ziyinxiehuo granules group (69 cases) and Zishenqinggan granules group(69 cases). Patients in Ziyinxiehuo granules group are treated with a series of experienced chinese herbal formulas, whereas the Zishenqinggan granules group received with different series of experienced chinese herbal formulas.
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
- Single (Participant)
入排标准
- 年龄范围
- — 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls are diagnosed as simple early breast development, and their age of onset is less than 8 years
- •Tanner stages of breast in female patients are Tanner II and Tanner III, Diameter of mammary nucleus is less than 3cm；
- •B-type ultrasonography: the size and volume of uterus and follicle is in the normal range at the same age；
- •bone age: the bone age in the patients are the same with their actual age.
排除标准
- •the bone age is advanced by more than 1 standard deviations for chronological age
- •pseudo sexual precocity, including gonadal tumor,adrenal disease,exogenous intake induced with hormone drugs or food and multiple bone fiber structure dysplasia of precocious puberty (McCune Albright syndrome)
- •heterosexual precocious puberty
- •In the mild true precocious puberty children：
- •Inclusion Criteria:
- •Girls are diagnosed as Idiopathic central precocious puberty，and their age of onset ≤8 years
- •Tanner stages of brest in female patients ≤ Tanner III stage，diameter of mammillary nucleus < 3cm
- •B-type ultrasonography: the volume of uterus≥1~3ml，the diameter of follicle≥4mm;or the length of uterus ≥3.4-4cm
- •bone age: compared the actual age ,the bone age is no more than 1 year and the bone age <10 years old;
- •in master single test: LH >3 IU/L
- •GnRH stimulation test: LH/FSH>0.6, the Peak LH 3.5~5.0 IU/L, the Peak LH 3.5~5.0 IU/L.
- •Exclusion Criteria:
- •The central nervous system organic diseases caused sexual precocity
- •congenital thyroid function reduce disease with precocious puberty, congenital adrenal hyperplasia, adrenal tumor
- •ovarian or testicular neoplasms,
- •McCune Albright syndrome (precocious puberty with polyostotic fibrous dysplasia and skin pigment abnormalities, pigmentation)
- •there is a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematosus, etc
- •precocious puberty and partial precocious puberty
研究组 & 干预措施
ziyinxiehuo Granules
Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months.
干预措施: ziyinxiehuo Granules (Drug)
zishenqinggan Granules
Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months.
干预措施: zishenqinggan Granules (Drug)
结局指标
主要结局
Change in some index of B type ultrasonography ( uterus,ovary,follicle )
时间窗: 3 months, 6months
The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )
次要结局
- change in the mammary nucleus index(3 months, 6 months)
- change in the cumulative score of traditional Chinese medicine syndromes(3 months, 6 months)
研究者
Jian Yu
Professor
Children's Hospital of Fudan University