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

NCT ID: NCT02650141

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 143 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2016-04-30

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.

Conditions

Precocious Puberty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ziyinxiehuo Granules

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

Group Type: EXPERIMENTAL

ziyinxiehuo Granules

Intervention Type: 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

zishenqinggan Granules

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

Group Type: ACTIVE_COMPARATOR

zishenqinggan Granules

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

nourishing"Yin"-removing"Fire" Granules; replenishing "Kidney"-Clearing "Liver" Granules

Eligibility Criteria

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.

• 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 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：

• 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

• Maximum Eligible Age: 8 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Jian Yu

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jian Y Jian, professor

Role: STUDY_CHAIR

Children Hospital of Fudan University

Locations

Department of Chinses Traditional Medcine； Children Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Countries

China

References

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.

Reference Type: RESULT

PMID: 32185991 (View on PubMed)

Other Identifiers

NO.12401905505

Identifier Type: -

Identifier Source: org_study_id