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

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ClinicalTrials.gov Identifier: NCT02650141
Recruitment Status : Unknown
Verified April 2016 by Jian Yu, Children's Hospital of Fudan University.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : May 3, 2016
Sponsor:
Information provided by (Responsible Party):
Jian Yu, Children's Hospital of Fudan University

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.

Condition or disease Intervention/treatment Phase
Precocious Puberty Drug: ziyinxiehuo Granules Drug: zishenqinggan Granules Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
Study Start Date : August 2013
Actual Primary Completion Date : March 2016
Estimated Study Completion Date : April 2017


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 Name: 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 Name: replenishing "Kidney"-Clearing "Liver" Granules




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   up to 8 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650141


Contacts
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Contact: Jian Y Jian, professor +86-18017590868 yuj@shmu.edu.cn

Locations
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China, Shanghai
Department of Chinses Traditional Medcine; Children Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Jian Y Jian, professor    +86-18017590868    yuj@shmu.edu.cn   
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Chair: Jian Y Jian, professor Children Hospital of Fudan University

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Responsible Party: Jian Yu, Professor, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02650141     History of Changes
Other Study ID Numbers: NO.12401905505
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: May 3, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will be used by the research group only.
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases