Effect of Prevalence of BMI on Efficacy of Herbal Medicines in Girls' Sexual Precocity
- Conditions
- Precocious Puberty
- Registration Number
- NCT04665713
- Lead Sponsor
- Children's 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 192
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Bone Age From enrollment to the sixth month after treatment growth of the difference between bone age and actual age after 6 months of treatment (in years)
- Secondary Outcome Measures
Name Time Method Ovarian Volume From enrollment to the sixth month after treatment development of uterine volume and ovarian volume after 6 months of treatment
Trial Locations
- Locations (1)
Children's Hospital of Fudan University
🇨🇳Shanghai, China