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Recruiting Phase 3 NCT06510764

A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty

Trial Parameters

Condition Precocious Puberty
Sponsor Children's Hospital of Fudan University
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 170
Sex FEMALE
Min Age 4 Years
Max Age 9 Years
Start Date 2024-09-15
Completion 2027-07-01
Interventions
intradermal needlesZiyinxiehuo Granules of traditional Chinese Medicine

Brief Summary

A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.

Eligibility Criteria

Inclusion Criteria: * Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years; * Tanner stages of breast in female patients ≤ Tanner III stage, diameters 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 less than 1 year and the bone age \<10 years old; * No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time. Exclusion Criteria: * 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.

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