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

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

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.

Study Overview

• Status: Completed
• Conditions: Precocious Puberty
• Intervention / Treatment: Drug: ziyinxiehuo Granules; Drug: zishenqinggan Granules

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 Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Department of Chinses Traditional Medcine； Children Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ziyinxiehuo Granules; Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months.	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; Other Names: nourishing"Yin"-removing"Fire" Granules
Active Comparator: zishenqinggan Granules; Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months.	Drug: 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; Other Names: replenishing "Kidney"-Clearing "Liver" Granules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Chair: Jian Y Jian, professor, Children Hospital of Fudan University

Publications and helpful links

General Publications

• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: January 4, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 8, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: November 27, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Puberty, Precocious
• Other Study ID Numbers: NO.12401905505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: The data will be used by the research group only.