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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Precocious Puberty

Intervention / Treatment
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* Drug: ziyinxiehuo Granules
* Drug: zishenqinggan Granules


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 8 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ziyinxiehuo Granules<br>Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months. | Drug: ziyinxiehuo Granules<br>* 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<br>* Other names: nourishingYin-removingFire Granules;|
| Active Comparator: zishenqinggan Granules<br>Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months. | Drug: zishenqinggan Granules<br>* 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<br>* Other names: replenishing Kidney-Clearing Liver Granules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 ) | 3 months, 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the mammary nucleus index | The investigators will measure the change of the mammary nucleus index by the mammary diameter | 3 months, 6 months | 
| 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 | 3 months, 6 months |