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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 : Completed
First Posted : January 8, 2016
Last Update Posted : December 3, 2019
Sponsor:
Information provided by (Responsible Party):
Jian Yu, Children's Hospital of Fudan University

Tracking Information
First Submitted Date  ICMJE January 4, 2016
First Posted Date  ICMJE January 8, 2016
Last Update Posted Date December 3, 2019
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
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 )
Original Primary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
Change in some index of B type ultrasonography ( uterus,ovary,follicle ) [ Time Frame: 3 months, 6months ]
We will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )
Change History Complete list of historical versions of study NCT02650141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 7, 2016)
  • change in the mammary nucleus index [ Time Frame: 3 months, 6 months ]
    We will measure the change of the mammary nucleus index by the mammary diameter
  • change in the cumulative score of traditional Chinese medicine syndromes [ Time Frame: 3 months, 6 months ]
    We 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
Official Title  ICMJE Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Precocious Puberty
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: ziyinxiehuo Granules
    Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months.
    Intervention: Drug: ziyinxiehuo Granules
  • Active Comparator: zishenqinggan Granules
    Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months.
    Intervention: Drug: zishenqinggan Granules
Publications * Sun Wen, Han Xinghui, Wang Yonghong, Yu Jian, Yan Weili, Zhao Jun, Chen Weibin, Xue Zheng. Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial. Journal of Traditional Chinese Medicine 38(5):740-745, 2018.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 27, 2019)
143
Original Estimated Enrollment  ICMJE
 (submitted: January 7, 2016)
138
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE
  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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02650141
Other Study ID Numbers  ICMJE NO.12401905505
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will be used by the research group only.
Responsible Party Jian Yu, Children's Hospital of Fudan University
Study Sponsor  ICMJE Children's Hospital of Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jian Y Jian, professor Children Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP