RecruitingPhase 3NCT06510764

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

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


Sponsor

Children's Hospital of Fudan University

Enrollment

170 participants

Start Date

Sep 15, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 4 YearsMax Age: 9 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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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Interventions

OTHERintradermal needles

Disposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days.

DRUGZiyinxiehuo Granules of traditional Chinese Medicine

Ziyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal.


Locations(2)

Children's Hospital of Fudan university

Shanghai, Shanghai Municipality, China

Children's Hospital of Fudan University

Shanghai, China

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NCT06510764


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