A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Jul 15, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment approach for girls with idiopathic precocious puberty, which is when puberty starts unusually early, before age 7.5. The researchers are exploring the effects of traditional Chinese medicine combined with a method called intradermal acupuncture, which involves gently stimulating certain points on the skin. The goal is to see if this combination can help manage the symptoms associated with early puberty.
To participate in the trial, girls must be diagnosed with idiopathic precocious puberty and meet specific health criteria, such as having certain breast development stages and bone age that is younger than their actual age. The trial is currently looking for girls aged between about 1.5 to 9 years who have not received other hormone treatments before. Participants will receive the new treatment and be monitored to see how well it works. This study aims to provide valuable insights into alternative medicine options for managing early puberty in children.
Gender
FEMALE
Eligibility 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.
About Children's Hospital Of Fudan University
The Children's Hospital of Fudan University is a leading pediatric healthcare institution in China, renowned for its commitment to advancing child health through innovative research and clinical excellence. As a prominent clinical trial sponsor, the hospital focuses on conducting high-quality, ethically-driven studies that aim to improve pediatric care and treatment outcomes. With a multidisciplinary team of experienced healthcare professionals and researchers, the hospital leverages its robust infrastructure and expertise to facilitate groundbreaking clinical trials, ensuring the safety and well-being of child participants while contributing valuable insights to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Shanghai, Shanghai, China
Patients applied
Trial Officials
Sun Yanyan, Master
Principal Investigator
Children's Hospital of Fudan University
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported