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

Fudan University

Status: Completed

Conditions: Precocious Puberty

Treatments: Drug: zishenqinggan Granules; Drug: ziyinxiehuo Granules

Study type: Interventional

Funder types: Other

Identifiers

NCT02650141

NO.12401905505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 143 patients

Sex: Female

Ages: Under 8 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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143 participants in 2 patient groups

ziyinxiehuo Granules

Experimental group

Description:

Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months.

Treatment:

Drug: ziyinxiehuo Granules

zishenqinggan Granules

Active Comparator group

Description:

Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months.

Treatment:

Drug: zishenqinggan Granules