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Study of Comprehensive Diagnosis and Treatment for Children Precocious Puberty

NCT ID: NCT02920515

Last Updated: 2016-09-30

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

Clinical Phase

PHASE4

Total Enrollment

740 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

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This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.

Detailed Description

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740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group. After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.

Conditions

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Central Precocious Puberty

Keywords

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epidemiology treatment molecular pathological mechanism environmental disrupting chemicals

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GnRHa(Triptorlin or Leuprorelin)

Triptorlin or Leuprelin 100ug/kg per 28 days

Group Type EXPERIMENTAL

Triptorlin or Leuprorelin

Intervention Type DRUG

Gonadotrophin releasing hormone agonists (GnRHa)

Traditional Chinese Medicines

Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months

Group Type ACTIVE_COMPARATOR

Zhibo dihuang pills

Intervention Type DRUG

Traditional Chinese Medicine

Dabu ying pills

Intervention Type DRUG

Traditional Chinese Medicine

blank group

without therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Triptorlin or Leuprorelin

Gonadotrophin releasing hormone agonists (GnRHa)

Intervention Type DRUG

Zhibo dihuang pills

Traditional Chinese Medicine

Intervention Type DRUG

Dabu ying pills

Traditional Chinese Medicine

Intervention Type DRUG

Other Intervention Names

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Triptorlin Leuprorelin

Eligibility Criteria

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Inclusion Criteria

1. Premature appearance of secondary sexual characteristics: girls present with development of secondary sexual characteristics before 8, with breast induration as the earliest manifestation.
2. Accelerated linear growth: the annual growth rate is higher than normal.
3. Advanced bone age: the bone age is 1 or years more than the actual age
4. Enlargement of sexual glands: B-mode ultrasonography of pelvic cavity indicates the volumes of the uterus and ovaries have increased, and multiple ovarian follicles with a diameter\>4mm can be found in ovaries;
5. HPGA functions have been primed; serum gonadotropin and sexual hormone levels reach pubertal values.
6. Subjects should be willing and able to follow the study protocol during the study period.
7. Subjects should submit their parents' or guardians' written informed consent before initiation of the study procedure with non-normal medical care. They should understand that subjects or their parents/guardians may withdraw the consent at any time without impairing future medical care. If the child is old enough to read and write, she should submit a separate consent form.

Exclusion Criteria

1. Patients with central nervous system diseases and thyroid diseases;
2. Patients with CHA-induced precocious puberty;
3. Patients with poor compliance.
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Children's Hospital

OTHER

Sponsor Role collaborator

Shanghai Children's Medical Center

OTHER

Sponsor Role collaborator

Xin Hua Hospital

OTHER

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

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WeiWang

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pin Li, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai Children's Hospital

Xuefan Gu, Dr

Role: PRINCIPAL_INVESTIGATOR

Xin Hua Hospital

Xiaodong Huang, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai children's medicial Center

Fan Jiang, Dr

Role: PRINCIPAL_INVESTIGATOR

Shanghai children's medicial Center

Other Identifiers

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12411950400

Identifier Type: -

Identifier Source: org_study_id