Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity

Study Overview
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Brief Summary
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Effect of Prevalence of Overweight and Obesity(Body Mass Index (BMI)) on Efficacy of herbal medicines(ZiYinXieHuo) in girls sexual Precocity

Detailed Description
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Herbal medicines(ZiYinXieHuo) might have implications for the effects of treatment. in sexual Precocity among the higher BMI girls. Thus the investigator use cohort studies to confirm this hypothesis. Selected children were from the precocious puberty clinic of the affiliated Pediatrics Hospital of Fudan University. Calculated according to the sample size (sample 6), the total number of cases was 192. All cases met the selected criteria. The subjects were divided into three groups according to the cut-off point of BMI of height and weight of Chinese children and adolescents (girls age in 2-18). Compared with children of the same age and sex, overweight group includes those BMI in the range of P85-P95, obese group includes those BMI greater than (or equal to) P95, and the girls whose BMI in the range of P5-P85 are assigned to the normal group. Chinese herbs for ZiYinXieHuo were used to treat girls with precocious puberty, only given by hospital preparation, drug dose: 30ml/once, 3 times a day. A course of treatment lasts for three months. In this study, two courses of treatment (6 months） were observed. The subjects would received three examinations: before taking the drug (baseline), the third month (metaphase) and the sixth month (end point).

Official Title
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Effect of Prevalence of Overweight and Obesity(Body Mass Index (BMI)) on Efficacy of Herbal Medicines(ZiYinXieHuo) in Girls' Sexual Precocity

Conditions
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Precocious Puberty

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - no abnormal weight and height in parents and families, no organic diseases, no drugs affecting gonadal axis or obesity; normal health, no secondary obesity caused by endocrine and genetic metabolic diseases, no lifestyle intervention to treat obesity. Exclusion Criteria: - central neoplastic lesions, rare syndrome, severe heart, liver and kidney diseases and other chronic diseases such as tuberculosis, asthma, rheumatism, complicated infection, congenital hypothyroidism associated with precocious puberty, peripheral precocious puberty, incomplete precocious puberty and so on.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 8 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>children whose BMI are in the normal range(From P5 to P85) | |
| Overweight<br>children whose BMI are above the normal range(over P85) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Age | growth of the difference between bone age and actual age after 6 months of treatment (in years) | From enrollment to the sixth month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian Volume | development of uterine volume and ovarian volume after 6 months of treatment | From enrollment to the sixth month after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Puberty