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

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ClinicalTrials.gov Identifier: NCT04665713
Recruitment Status : Recruiting
First Posted : December 14, 2020
Last Update Posted : February 17, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

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

Condition or disease
Precocious Puberty

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).
Study Design
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Study Type : Observational
Estimated Enrollment : 192 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Prevalence of Overweight and Obesity(Body Mass Index (BMI)) on Efficacy of Herbal Medicines(ZiYinXieHuo) in Girls' Sexual Precocity
Actual Study Start Date : December 18, 2020
Estimated Primary Completion Date : November 30, 2022
Estimated Study Completion Date : December 10, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Normal
children whose BMI are in the normal range(From P5 to P85)
Overweight
children whose BMI are above the normal range(over P85)


Outcome Measures
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Primary Outcome Measures :
  1. Bone Age [ Time Frame: 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 :
  1. Ovarian Volume [ Time Frame: From enrollment to the sixth month after treatment ]
    development of uterine volume and ovarian volume after 6 months of treatment


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Precocious puberty is more common in girls than boys
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Selected children were from the precocious puberty clinic of the affiliated Pediatrics Hospital of Fudan University.
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665713


Contacts
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Contact: Wen Sun (86)13818844692 sunwenhere@163.com

Locations
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China
Children's Hospital of Fudan University Recruiting
Shanghai, China, 201102
Contact: Wen Sun    (86)13818844692    sunwenhere@163.com   
Sponsors and Collaborators
Children's Hospital of Fudan University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT04665713    
Other Study ID Numbers: ZY3-RCPY-2-2021
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: February 17, 2022
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
Puberty
Additional relevant MeSH terms:
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Puberty, Precocious
Gonadal Disorders
Endocrine System Diseases