NCT06510764 A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
| NCT ID | NCT06510764 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Precocious Puberty |
| Study Type | INTERVENTIONAL |
| Enrollment | 170 participants |
| Start Date | 2024-09-15 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 170 participants in total. It began in 2024-09-15 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sun Yanyan, Master
PRINCIPAL INVESTIGATOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06510764 clinical trial?
This trial is open to female participants only, aged 4 Years or older, up to 9 Years, studying Precocious Puberty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06510764 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 170 participants.
Is NCT06510764 currently recruiting?
Yes, NCT06510764 is actively recruiting participants. Contact the research team at 1055952886@qq.com for enrollment information.
Where is the NCT06510764 trial being conducted?
This trial is being conducted at Shanghai, China, Shanghai, China.
Who is sponsoring the NCT06510764 clinical trial?
NCT06510764 is sponsored by Children's Hospital of Fudan University. The principal investigator is Sun Yanyan, Master at Children's Hospital of Fudan University. The trial plans to enroll 170 participants.