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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Precocious Puberty; Alternative Medicine; Treatment; Acupuncture

Treatments: Drug: Ziyinxiehuo Granules of traditional Chinese Medicine; Other: intradermal needles

Study type: Interventional

Funder types: Other

Identifiers

NCT06510764

23Y11921100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 4 to 9 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

170 participants in 2 patient groups

Traditional Chinese Medicine+acupuncture

Experimental group

Description:

Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.

Treatment:

Other: intradermal needles

Drug: Ziyinxiehuo Granules of traditional Chinese Medicine

Traditional Chinese Medicine

Active Comparator group

Description:

Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.

Treatment:

Drug: Ziyinxiehuo Granules of traditional Chinese Medicine