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

NCT02650141 | Completed

• 1 other identifier: NO.12401905505
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Precocious Puberty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• change in the mammary nucleus index

  3 months, 6 months

• change in the cumulative score of traditional Chinese medicine syndromes

  3 months, 6 months

Study Arms (2)

ziyinxiehuo Granules

EXPERIMENTAL

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

Drug: ziyinxiehuo Granules

zishenqinggan Granules

ACTIVE COMPARATOR

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

Drug: zishenqinggan Granules

Interventions

ziyinxiehuo Granules DRUG

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

Also known as: nourishing"Yin"-removing"Fire" Granules

ziyinxiehuo Granules

zishenqinggan Granules DRUG

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

Also known as: replenishing "Kidney"-Clearing "Liver" Granules

zishenqinggan Granules

Eligibility Criteria

• Age: Up to 8 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• In the mild true precocious puberty children：
• 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.
• 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

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Department of Chinses Traditional Medcine； Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (1)

• 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.

  PMID: 32185991 RESULT

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Officials

• Jian Y Jian, professor

  Children Hospital of Fudan University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2016
• First Posted: January 8, 2016
• Study Start: April 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: April 1, 2016
• Last Updated: December 3, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)