search
Back to results

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

Primary Purpose

Precocious Puberty

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ziyinxiehuo Granules
zishenqinggan Granules
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Precocious Puberty

Eligibility Criteria

undefined - 8 Years (Child)FemaleDoes not accept healthy volunteers

  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

Sites / Locations

  • Department of Chinses Traditional Medcine； Children Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ziyinxiehuo Granules

zishenqinggan Granules

Arm Description

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

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

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

change in the mammary nucleus index
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
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

Full Information

First Posted
January 4, 2016
Last Updated
November 27, 2019
Sponsor
Children's Hospital of Fudan University
search

1. Study Identification

Unique Protocol Identification Number
NCT02650141
Brief Title
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
Official Title
Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
April 2013 (Actual)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Precocious Puberty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ziyinxiehuo Granules
Arm Type
Experimental
Arm Description
Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months.
Arm Title
zishenqinggan Granules
Arm Type
Active Comparator
Arm Description
Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months.
Intervention Type
Drug
Intervention Name(s)
ziyinxiehuo Granules
Other Intervention Name(s)
nourishing"Yin"-removing"Fire" Granules
Intervention Description
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
Intervention Name(s)
zishenqinggan Granules
Other Intervention Name(s)
replenishing "Kidney"-Clearing "Liver" Granules
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in some index of B type ultrasonography ( uterus,ovary,follicle )
Description
The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )
Time Frame
3 months, 6months
Secondary Outcome Measure Information:
Title
change in the mammary nucleus index
Description
The investigators will measure the change of the mammary nucleus index by the mammary diameter
Time Frame
3 months, 6 months
Title
change in the cumulative score of traditional Chinese medicine syndromes
Description
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
Time Frame
3 months, 6 months

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Y Jian, professor
Organizational Affiliation
Children Hospital of Fudan University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Chinses Traditional Medcine； Children Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The data will be used by the research group only.
Citations:
PubMed Identifier
32185991
Citation
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.
Results Reference
result
Links:
URL
http://www.journaltcm.com/modules/Journal/contents/stories/185/10.pdf
Description
Title:Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial.

Learn more about this trial

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

We'll reach out to this number within 24 hrs