Combining traditional Chinese medicine and acupuncture for treating early puberty in girls

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness of traditional Chinese medicine and intradermal acupuncture in treating girls diagnosed with idiopathic precocious puberty. The study will involve a randomized controlled design to assess whether this combined approach can enhance therapeutic outcomes and prevent the progression of mild to moderate cases of precocious puberty. Participants will receive treatment with Ziyinxiehuo Granules and intradermal needles, focusing on regulating hormone levels and ovarian function. The trial seeks to provide clinical evidence for a novel treatment strategy in this area.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital of Fudan university
  Shanghai, Shanghai Municipality, China Recruiting
• Children's Hospital of Fudan University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Sun Yanyan, Master — Children's Hospital of Fudan University
• Study coordinator: Han Xinghui, Master
• Email: 1055952886@qq.com
• Phone: 021-64931219

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.