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A prospective cohort study of Da Bu Yin Pill (Concentrated Pill) for the treatment of precocious puberty

A prospective cohort study of Da Bu Yin Pill (Concentrated Pill) for the treatment of precocious puberty

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002349
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-05-30
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Precocious puberty in children

Interventions

Isolated premature breast development non-exposed group:Do not use the Great Yin Tonic Pill.
Group exposed to isolated early breast development:Use the Great Yin Tonic Pill
Idiopathic central precocious puberty non-exposed group:Do not use Dabu Yinwan or similar traditional Chinese medicines, but Western medical treatments can be used
Idiopathic central precocious puberty exposure group:You can use Western medicine if you use Da Bu Yin Wan but do not use similar traditional Chinese patent medicines

Sponsors

Children's Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 10 Years

Inclusion criteria

Inclusion criteria: According to the classification of precocious puberty and the characteristics of clinical treatment the target population of this study was "simple precocious breast development" in partial precocious puberty and "idiopathic central precocious puberty" in central precocious puberty. The main syndrome types of traditional Chinese medicine are all yin deficiency and fire prosperity syndrome.

Exclusion criteria

Exclusion criteria: Confirmed by the judgement of the study physician.

Design outcomes

Primary

MeasureTime frame
Bone;Hormones six;Ovarian volume;Testicular volume;Nipple diameter;Cranial MRI;Blood routine;Urinalysis;Routine;Liver and kidney function;Electrocardiogram;Uterine length;Breast staging;

Countries

China

Contacts

Public Contactyujian

Children's Hospital of Fudan University

yuj@shmu.edu.cn13816881206

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026