Combining traditional Chinese medicine and acupuncture for treating early puberty in girls
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
This study is testing whether a combination of traditional Chinese medicine and acupuncture can help girls with early puberty feel better and manage their symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 4 Years to 9 Years |
| Sex | Female |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT06510764 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of traditional Chinese medicine and intradermal acupuncture in treating girls diagnosed with idiopathic precocious puberty. The study will involve a randomized controlled design to assess whether this combined approach can enhance therapeutic outcomes and prevent the progression of mild to moderate cases of precocious puberty. Participants will receive treatment with Ziyinxiehuo Granules and intradermal needles, focusing on regulating hormone levels and ovarian function. The trial seeks to provide clinical evidence for a novel treatment strategy in this area.
Who should consider this trial
Good fit: Ideal candidates for this study are girls diagnosed with idiopathic precocious puberty, aged 7.5 years or younger, who meet specific clinical criteria.
Not a fit: Patients with precocious puberty caused by central nervous system disorders or other specific medical conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive treatment option for managing early puberty in girls, potentially preventing more severe complications.
How similar studies have performed: While acupuncture has shown effectiveness in related conditions, there is limited clinical evidence specifically addressing idiopathic precocious puberty, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality and 1 other locations
- Children's Hospital of Fudan university — Shanghai, Shanghai Municipality, China (Recruiting)
- Children's Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Sun Yanyan, Master — Children's Hospital of Fudan University
- Study coordinator: Han Xinghui, Master
- Email: 1055952886@qq.com
- Phone: 021-64931219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.