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

Last updated: January 21, 2025
Sponsor: Children's Hospital of Fudan University
Overall Status: Active - Recruiting

Phase

3

Condition

Precocious Puberty

Hypogonadism

Treatment

intradermal needles

Ziyinxiehuo Granules of tradional Chinese Medicine

Ziyinxiehuo Granules of traditional Chinese Medicine

Clinical Study ID

NCT06510764
23Y11921100
  • Ages 4-9
  • Female

Study 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 Criteria

Inclusion

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 ofmammillary nucleus ≤ 3cm; •B-type ultrasonography: the volume of uterus≥ 3ml, thevolume of ovary≥1.5ml, the diameter of follicle≥4mm;

  • Bone age: compared the chronological age, the bone age is less than 1 year and thebone age <10 years old;

  • No GnRH analogs or Sex hormones were administrated in the past; and All above areneeded at the same time.

Exclusion

Exclusion Criteria:

  • Precocity caused by the central nervous system organic diseases;

  • Precocious precocity caused by congenital hypothyroidism, congenital adrenalhyperplasia, adrenal tumor and ovarian or testicular neoplasms as well asMcCune-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.

Study Design

Total Participants: 170
Treatment Group(s): 3
Primary Treatment: intradermal needles
Phase: 3
Study Start date:
September 15, 2024
Estimated Completion Date:
July 01, 2027

Study 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.

Connect with a study center

  • Children's Hospital of Fudan university

    Shanghai, Shanghai 201102
    China

    Active - Recruiting

  • Children's Hospital of Fudan University

    Shanghai, 201102
    China

    Active - Recruiting

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