Trials Sponsors Conditions Drugs Pricing

Conditions

Idiopathic Precocious Puberty

Keywords

Idiopathic Precocious PubertyRapid ProgressiveIntegrative Chinese and Western MedicineEvidence-based Medicine

Outcome Measures

Primary Outcomes (1)

Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
The investigators will measure subjects' mammary nucleus diameter through the midline of the breast with a ruler after six months of continuous treatment, and percentage of the mammary nucleus diameter reduced to less than 1cm in each group will be calculated.
After six months of continuous treatment

Secondary Outcomes (1)

Ratio of bone age difference to chronological age difference
After six months of continuous treatment

Study Arms (2)

Ziyinxiehuo Granules and Megestrol Acetate

EXPERIMENTAL

Experimental：Group Ziyinxiehuo Granules and Megestrol Acetate Tablet Intervention :Subjects in Group Ziyinxiehuo Granules and megestrol acetate tablet will be treated with Ziyinxiehuo Granules and megestrol acetate tablet for 6 months.1 pack of Ziyinxiehuo granules Herbs includes shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g. Ziyinxiehuo Granules is administered after dissolved,1pack every time, 2 times per day after a meal; and the dosage of megestrol acetate is 6-8mg/d, which is taken in 3 times after a meal.

Drug: Ziyinxiehuo Granules HerbsDrug: Megestrol Acetate Tablet

Gonadotrophin

ACTIVE COMPARATOR

Active Comparator: Group Gonadotrophin Intervention: Subjects in Group Gonadotrophin will be treated with gonadotrophin releasing hormone agonist for 6months. In our study Leuprorelin Acetate 3.75mg Injection will be applied, the dosage of which is 80μg/kg every time by subcutaneous injection, every 4 weeks for once.

Interventions

Ziyinxiehuo Granules HerbsDrug

1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.

Also known as: nourishing"Yin"-removing"Fire" Granules

Ziyinxiehuo Granules and Megestrol Acetate

Megestrol Acetate TabletDrug

the dose is 6-8mg/d, three times per day after meals.

Eligibility Criteria

Age5 Years - 8 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;
Tanner stages of breast in female patients ≥ Tanner III stage，diameter of mammillary nucleus ≥ 3cm;

Sponsors & Collaborators

Children's Hospital of Fudan University
Otherlead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

MeSH Terms

Interventions

Megestrol AcetateLeuprolideInjections

Intervention Hierarchy (Ancestors)

MegestrolPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsGonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

Jian Yu, professor
Children's Hospital of Fudan University
STUDY CHAIR

Enrollment

126 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Director of TCM Department

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 28, 2019

Study Start

August 15, 2019

Actual (reported)

Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Ziyinxiehuo Granules and Megestrol Acetate

Gonadotrophin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Ziyinxiehuo Granules and Megestrol Acetate

Gonadotrophin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations