Clinical trial NCT06510764: A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
Official title: A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Precocious Puberty
Treatment
Alternative Medicine
Acupuncture
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2024-07-19
Enrollment: 170
Sex: FEMALE
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.

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.

Primary outcomes:
measure: The percentage of subjects' mammary nucleus minification or disappearance at the third month.
timeFrame: from baseline to the third month.
Secondary outcomes:
measure: the change in bone age／the change in chronological age after six months
timeFrame: from baseline to the sixth month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan university
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
affiliation: Children's Hospital of Fudan University
name: Sun Yanyan, Master
role: PRINCIPAL_INVESTIGATOR
References: