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

NCT03963752 | Completed Phase 4 DMC

• 1 other identifier: 18401902300
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.

Conditions

Idiopathic Precocious Puberty

Keywords

Idiopathic Precocious Puberty; Rapid Progressive; Integrative Chinese and Western Medicine; Evidence-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 Herbs; Drug: 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.

Drug: Leuprorelin Acetate 3.75mg Injection

Interventions

Ziyinxiehuo Granules Herbs DRUG

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 Tablet DRUG

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

Ziyinxiehuo Granules and Megestrol Acetate

Leuprorelin Acetate 3.75mg Injection DRUG

Usage： 80μg/kg by subcutaneous injection, every 4 weeks

Gonadotrophin

Eligibility Criteria

• Age: 5 Years - 8 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (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;
• B-type ultrasonography: the volume of uterus≥3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;
• Bone age: compared the chronological age, the bone age is more than 1 year and the bone age \<11.5 years old;
• It progresses rapidly, ratio of bone age difference to chronological age difference\> 1;
• No GnRH analogs or sex hormones were administrated in the past;
• All above are needed at the same time.

You may not qualify if:

• Precocious precocity caused by the central nervous system organic diseases;
• Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;
• Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;
• Pseudo sexual precocity and partial precocious puberty.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

MeSH Terms

Interventions

Megestrol Acetate; Leuprolide; Injections

Intervention Hierarchy (Ancestors)

Megestrol; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jian Yu, professor

  Children's Hospital of Fudan University

  STUDY CHAIR

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
• Primary Completion: August 15, 2022
• Study Completion: September 30, 2022
• Last Updated: February 7, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)