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

Phase 3

Recruiting

• Conditions: Precocious Puberty; Treatment; Alternative Medicine; Acupuncture
• Interventions: Other: intradermal needles; Drug: Ziyinxiehuo Granules of traditional Chinese Medicine

• Registration Number: NCT06510764
• Lead Sponsor: Children's Hospital of Fudan University

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.

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Study Start: 2024-09-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2027-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 170

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese Medicine+acupuncture	intradermal needles	Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
Traditional Chinese Medicine+acupuncture	Ziyinxiehuo Granules of traditional Chinese Medicine	Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
Traditional Chinese Medicine	Ziyinxiehuo Granules of traditional Chinese Medicine	Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.

Primary Outcome Measures

Name	Time	Method
The percentage of subjects' mammary nucleus minification or disappearance at the third month.	from baseline to the third month.	The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.

Secondary Outcome Measures

Name	Time	Method
the change in bone age／the change in chronological age after six months	from baseline to the sixth month	The bone age will be measured with X-ray and evaluated with G-P Atlas method at baseline and the sixth month. the change in bone age= bone age after six months-bone age at baseline, the change in chronological age is six months.

Trial Locations

Locations (2)

Children's Hospital of Fudan university; 🇨🇳 Shanghai, Shanghai, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China