A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
Recruiting
Phase 3
Interventional Study
Precocious Puberty
Treatment
Alternative Medicine
Acupuncture
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 4 – 9
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 170 (estimated)
- Sponsor
- Children's Hospital of Fudan University · Other
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About This Trial
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.
Trial Locations
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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 di…
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