Clinical trial NCT04665713: Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
Official title: Effect of Prevalence of Overweight and Obesity(Body Mass Index (BMI)) on Efficacy of Herbal Medicines(ZiYinXieHuo) in Girls' Sexual Precocity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Precocious Puberty
Keywords: Puberty
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 192
Sex: FEMALE
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Selected children were from the precocious puberty clinic of the affiliated Pediatrics Hospital of Fudan University.

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

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Bone Age
timeFrame: From enrollment to the sixth month after treatment
Secondary outcomes:
measure: Ovarian Volume
timeFrame: From enrollment to the sixth month after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References:
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