Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty

Children's Hospital of Fudan University143 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

143

Conditions

Precocious Puberty

Interventions

ziyinxiehuo GranulesDRUG

Ziyinxiehuo granules Herbs (1 bag ): shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g Therapeutic Principle: Nourishing "Yin", removing "Fire" Usage: administered after dissolved, 3 times per day after breakfast and supper

zishenqinggan GranulesDRUG

Zishenqinggan granules Herbs (1 bag ): Shengdi 5g, baishao 3g, huangqin 3g, fuling 4g, danpi 3g, maiya 6g, shanzha 3g, zhebei 3g, zhigancao 2g Therapeutic Principle: replenishing "Kidney", Clearing "Liver" Usage: administered after dissolved, 3 times per day after breakfast and supper

Eligibility

Sex: FEMALEMax age: 8 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Chinses Traditional Medcine； Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Change in some index of B type ultrasonography ( uterus,ovary,follicle )

The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )

Time frame: 3 months, 6months

Secondary Outcomes

change in the mammary nucleus index

The investigators will measure the change of the mammary nucleus index by the mammary diameter

Time frame: 3 months, 6 months

change in the cumulative score of traditional Chinese medicine syndromes

The investigators will measure the change in scores of chinese medicine symptoms according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe

Time frame: 3 months, 6 months

Data from ClinicalTrials.gov

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