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

Precocious Puberty Clinical Trial

Official title:

Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02650141
• Other study ID #: NO.12401905505
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2016

Study information

• Verified date: November 2019
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: April 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Intervention

Drug:
• ziyinxiehuo Granules
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 Granules
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

Locations

Country	Name	City	State
China	Department of Chinses Traditional Medcine; Children Hospital of Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (1)

Sun Wen, Han Xinghui, Wang Yonghong, Yu Jian, Yan Weili, Zhao Jun, Chen Weibin, Xue Zheng. Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 )	3 months, 6months
Secondary	change in the mammary nucleus index	The investigators will measure the change of the mammary nucleus index by the mammary diameter	3 months, 6 months
Secondary	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	3 months, 6 months

External Links

•   Title:Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial.