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

Not Applicable

Completed

• Conditions: Precocious Puberty
• Interventions: Drug: ziyinxiehuo Granules; Drug: zishenqinggan Granules

• Registration Number: NCT02650141
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2015-11
• Study First Submitted: 2016-01-04
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Study Completion: 2016-04
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-27
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 143

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
change in the mammary nucleus index	3 months, 6 months	The investigators will measure the change of the mammary nucleus index by the mammary diameter
change in the cumulative score of traditional Chinese medicine syndromes	3 months, 6 months	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

Trial Locations

Locations (1)

Department of Chinses Traditional Medcine； Children Hospital of Fudan University; 🇨🇳 Shanghai, Shanghai, China