Status:
RECRUITING
A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Precocious Puberty
Treatment
Eligibility:
FEMALE
4-9 years
Phase:
PHASE3
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.
Detailed Description
Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06510764
Start Date
September 15 2024
End Date
July 1 2027
Last Update
January 23 2025
Active Locations (2)
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1
Children's Hospital of Fudan university
Shanghai, Shanghai Municipality, China, 201102
2
Children's Hospital of Fudan University
Shanghai, China, 201102