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NCT Number: NCT02650141

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

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.

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Key information

Age range

Up to 8 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Chinses Traditional Medcine; Children Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

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

Other names: nourishing"Yin"-removing"Fire" 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

Other names: replenishing "Kidney"-Clearing "Liver" Granules

Primary outcomes

  1. Change in some index of B type ultrasonography ( uterus,ovary,follicle )

    Time frame: 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 outcomes

  1. change in the mammary nucleus index

    Time frame: 3 months, 6 months

    The investigators will measure the change of the mammary nucleus index by the mammary diameter

  2. change in the cumulative score of traditional Chinese medicine syndromes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jan 8, 2016
Registry last updated
Dec 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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