NCT06820931

Brief Summary

1\. Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. Assess the therapeutic effect of nourishing yin and purging fire traditional Chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional Chinese medicine

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 11, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

February 11, 2025

Status Verified

February 1, 2025

Enrollment Period

12 months

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

Puberty Changes

Keywords

TCMpuberty

Outcome Measures

Primary Outcomes (1)

  • The incidence of rapid progression type of precocious puberty

    The incidence of rapid progression type of precocious puberty between two groups.

    From enrollment to 6 months after treatment.

Secondary Outcomes (2)

  • AMH

    From enrollment to 6 months after treatment.

  • SHBG

    From enrollment to 6 months after treatment.

Other Outcomes (13)

  • Height

    From enrollment to 6 months after treatment.

  • Weight

    From enrollment to 6 months after treatment.

  • Bone age

    From enrollment to 6 months after treatment.

  • +10 more other outcomes

Study Arms (2)

Control group

NO INTERVENTION

This group does not receive any intervention.

Intervention group

EXPERIMENTAL

The intervention group is administered drug therapy for a period of six months.

Drug: Xuandi Ziyin Mixture

Interventions

Xuandi Ziyin MixtureDRUG

Treatment is given only with the hospital preparation 'Xuandi Ziyin Mixture' with a dosage of 30ml per administration three times a day.

Intervention group

Eligibility Criteria

Age8 Years - 9 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Girls with an onset age \>8 years and ≤9 years;
  • Breast bud Tanner stage II breast bud diameter \<3 cm;
  • Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm;
  • Bone age does not exceed actual age by more than 1 year;
  • LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L.
  • Good compliance;
  • Patients and their parents are willing to actively cooperate with the clinical trial;
  • Legal guardian signs the informed consent form.

You may not qualify if:

  • Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.;
  • Use of treatments that affect gonadal function such as chemotherapy radiotherapy;
  • Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

Central Study Contacts

Wen Sun

CONTACT

8613818844692sunwenhere@163.com

Teng Fan

CONTACT

8619921314120fantengcn@163.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
In this study, 80 patients with premature puberty are included by simple randomization. The randomization scheme is generated by an independent statistical team from the Clinical Trial Center of Children's Hospital of Fudan University using SAS 9.4 software. The intervention protocol determined by the random allocation sequence will be managed by a central coordinator who is not involved in the implementation of the intervention or outcome assessment. The central coordinator will inform the researchers involved in the study of the allocation scheme for the study subjects in accordance with the order in which the guardians of the study subjects sign the informed consent form. The doctor in charge of outcome assessment is completely unaware of the group assignment of the study subjects.
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 11, 2025

Study Start

January 1, 2025

Primary Completion

December 31, 2025

Study Completion

February 28, 2026

Last Updated

February 11, 2025

Record last verified: 2025-02

Locations

CN(1)