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

NCT ID: NCT04665713

Last Updated: 2023-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

192 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-18

Study Completion Date

2023-07-04

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).

Conditions

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Precocious Puberty

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal

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

No interventions assigned to this group

Overweight

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

No interventions assigned to this group

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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

8 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital of Fudan University

Shanghai, , China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 26310550 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 5785179 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27384405 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27928854 (View on PubMed)

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.

Reference Type RESULT
PMID: 15132858 (View on PubMed)

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.

Reference Type RESULT
PMID: 19951508 (View on PubMed)

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.

Reference Type RESULT
PMID: 21163089 (View on PubMed)

Other Identifiers

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ZY3-RCPY-2-2021

Identifier Type: -

Identifier Source: org_study_id

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