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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age4-9
SponsorChildren's Hospital of Fudan University

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • intradermal needles
  • Ziyinxiehuo Granules of traditional Chinese Medicine

Treatment groups

170 Participants
are divided into 2 treatment groups