Clinical trial NCT02650141: Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
Official title: Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Precocious Puberty
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 143
Sex: FEMALE
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 1. In the partial precocious puberty children：

   Inclusion Criteria:
   * 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.

   Exclusion Criteria:
   * 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
2. 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

Primary outcomes:
measure: Change in some index of B type ultrasonography ( uterus,ovary,follicle )
timeFrame: 3 months, 6months
Secondary outcomes:
measure: change in the mammary nucleus index
timeFrame: 3 months, 6 months
measure: change in the cumulative score of traditional Chinese medicine syndromes
timeFrame: 3 months, 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Chinses Traditional Medcine； Children Hospital of Fudan University
state: Shanghai
Study officials:
affiliation: Children Hospital of Fudan University
name: Jian Y Jian, professor
role: STUDY_CHAIR
References:
citation: Sun W, Han X, Wang Y, Yu J, Yan W, Zhao J, Chen W, Xue Z. Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial. J Tradit Chin Med. 2018 Oct;38(5):740-745.