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NCT Number: NCT03963752

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

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.

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Key information

Age range

5 year–8 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

About this study

In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet(82 cases)and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Ziyinxiehuo Granules Herbs

Drug

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

Other names: nourishing"Yin"-removing"Fire" Granules

Megestrol Acetate Tablet

Drug

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

Leuprorelin Acetate 3.75mg Injection

Drug

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

Primary outcomes

  1. Percentage of the Mammary Nucleus Diameter reduced to less than 1cm

    Time frame: After six months of continuous treatment

    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.

Secondary outcomes

  1. Ratio of bone age difference to chronological age difference

    Time frame: After six months of continuous treatment

    The left hand orthotopic X-ray (including the carpal bone and the lower end of the ulna) will be filmed by the Department of Radiology before and after treatment, and the bone age will be measured according to the Greulich-Pyle map method. Ratio of bone age difference to chronological age difference will be calculated.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Registry information

Official study title

Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 28, 2019
Registry last updated
Feb 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.