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

Precocious Puberty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665713
• Other study ID #: ZY3-RCPY-2-2021
• Status: Completed
• Start date: December 18, 2020
• Est. completion date: July 4, 2023

Study information

• Verified date: July 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 4, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Precocious Puberty
• Puberty, Precocious

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

References & Publications (7)

Fugl L, Hagen CP, Mieritz MG, Tinggaard J, Fallentin E, Main KM, Juul A. Glandular breast tissue volume by magnetic resonance imaging in 100 healthy peripubertal girls: evaluation of clinical Tanner staging. Pediatr Res. 2016 Oct;80(4):526-30. doi: 10.1038/pr.2016.125. Epub 2016 Jun 3. — View Citation

Group of China Obesity Task Force. [Body mass index reference norm for screening overweight and obesity in Chinese children and adolescents]. Zhonghua Liu Xing Bing Xue Za Zhi. 2004 Feb;25(2):97-102. Chinese. — View Citation

Li H, Ji CY, Zong XN, Zhang YQ. [Body mass index growth curves for Chinese children and adolescents aged 0 to 18 years]. Zhonghua Er Ke Za Zhi. 2009 Jul;47(7):493-8. Chinese. — View Citation

Li H, Zong XN, Ji CY, Mi J. [Body mass index cut-offs for overweight and obesity in Chinese children and adolescents aged 2 - 18 years]. Zhonghua Liu Xing Bing Xue Za Zhi. 2010 Jun;31(6):616-20. Chinese. — View Citation

Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969 Jun;44(235):291-303. doi: 10.1136/adc.44.235.291. No abstract available. — View Citation

Sheth SS, Hajari AR, Lulla CP, Kshirsagar D. Sonographic evaluation of uterine volume and its clinical importance. J Obstet Gynaecol Res. 2017 Jan;43(1):185-189. doi: 10.1111/jog.13189. Epub 2016 Dec 8. — View Citation

Subspecialty Group of Endocrinologic, Hereditary and Metabolic Diseases, the Society of Pediatrics, Chinese Medical Association; Editorial Board, Chinese Journal of Pediatrics. [Consensus statement For the diagnosis and treatment of central precocious puberty (2015)]. Zhonghua Er Ke Za Zhi. 2015 Jun;53(6):412-8. No abstract available. Chinese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Ovarian Volume	development of uterine volume and ovarian volume after 6 months of treatment	From enrollment to the sixth month after treatment