Puberty ChangesPhase 4NCT06820931
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
A Phase 4 study testing Xuandi Ziyin Mixture in people with Puberty Changes, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 9 years, women only
- Conditions the study is for
- Puberty Changes
- What is being tested?
- Xuandi Ziyin Mixture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 28 Feb 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 9 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
- 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
- Conditions
- Puberty Changes
- Being tested
- Xuandi Ziyin Mixture
- Keywords
- TCM, puberty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Xuandi Ziyin Mixture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of rapid progression type of precocious puberty
The incidence of rapid progression type of precocious puberty between two groups.
Measured: From enrollment to 6 months after treatment.
Secondary outcomes (2)
AMH
Anti-Müllerian Hormone (ng/ml, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay.
Measured: From enrollment to 6 months after treatment.
SHBG
Sex Hormone Binding Globulin(nmol/L, detected from the blood) Blood samples are collected from all patients in the morning after an overnight fast. Hormone levels are measured using chemiluminescent immunoassay.
Measured: From enrollment to 6 months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puberty ChangesStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06820931
- Sponsor's protocol ID
- FDCH-ZYXZS-2024313
- Other IDs
- Z-2019-41-2101-02
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
- ClinicalTrials.gov ID
- NCT06820931
- Acronym / sponsor ID
- FDCH-ZYXZS-2024313
- Conditions
- Puberty Changes
- Keywords
- TCM, puberty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 11 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group does not receive any intervention. |
| Intervention group | Experimental | Drug: Xuandi Ziyin MixtureThe intervention group is administered drug therapy for a period of six months. |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuandi Ziyin MixtureTreatment is given only with the hospital preparation 'Xuandi Ziyin Mixture' with a dosage of 30ml per administration three times a day. | Drug | Intervention group |
Primary outcome
The incidence of rapid progression type of precocious puberty
Time frame: From enrollment to 6 months after treatment.
The incidence of rapid progression type of precocious puberty between two groups.
2 secondary outcomes
AMH
Time frame: From enrollment to 6 months after treatment.
SHBG
Time frame: From enrollment to 6 months after treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Puberty Changes
Not yet recruiting
Improving Health Among Disadvantaged Girls to Slow Pubertal Onset and Reduce Long-term Health Risks
Overweight/Obesity, Puberty
RecruitingEarly Phase 1
Hyperandrogenemia and Altered Day-night LH Pulse Patterns
Hyperandrogenism, Polycystic Ovary Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xuandi Ziyin Mixture in people with Puberty Changes, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Sun (8613818844692, sunwenhere@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of rapid progression type of precocious puberty (time frame: From enrollment to 6 months after treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.