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

NCT04665713 | Completed

• 1 other identifier: ZY3-RCPY-2-2021
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Precocious Puberty

Keywords

Puberty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Ovarian Volume

  From enrollment to the sixth month after treatment

Study Arms (2)

Normal

children whose BMI are in the normal range(From P5 to P85)

Overweight

children whose BMI are above the normal range(over P85)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Gender Eligibility Details: Precocious puberty is more common in girls than boys
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Selected children were from the precocious puberty clinic of the affiliated Pediatrics Hospital of Fudan University.

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

Related Publications (7)

• 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.

  PMID: 26310550 BACKGROUND

• 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.

  PMID: 5785179 BACKGROUND

• 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.

  PMID: 27384405 BACKGROUND

• 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.

  PMID: 27928854 BACKGROUND

• 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.

  PMID: 15132858 RESULT

• 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.

  PMID: 19951508 RESULT

• 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.

  PMID: 21163089 RESULT

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2020
• First Posted: December 14, 2020
• Study Start: December 18, 2020
• Primary Completion: November 30, 2022
• Study Completion: July 4, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

CN (1)