Precocious PubertyPhase 3NCT06510764
A Trial of Chinese Traditional Medicine Combining With Intradermal Acupuncture for Treating Precocious Puberty
A Phase 3 study testing intradermal needles and Ziyinxiehuo Granules of traditional Chinese Medicine in people with Precocious Puberty and Treatment, run by Children's Hospital of Fudan University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 9 years, women only
- Conditions the study is for
- Precocious Puberty, Treatment, Alternative Medicine
- What is being tested?
- intradermal needles and Ziyinxiehuo Granules of traditional Chinese Medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesChina
- Study dates
- 15 Sep 2024to 1 Jul 2027
- Phase
- Phase 3
- 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 4 to 9 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Children's Hospital of Fudan university
Shanghai, Shanghai Municipality, 201102
Sun Yanyan, Master, 02164931219, sunyanyan09@fudan.edu.cn
- Recruiting
Children's Hospital of Fudan University
Shanghai, 201102
Sun Yanyan, master, 02164931219, sunyanyan09@fudan.edu.cn
About this study
Official title: A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity
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.
Read the detailed description
Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.
- Conditions
- Precocious Puberty, Treatment, Alternative Medicine, Acupuncture
- Being tested
- intradermal needles, Ziyinxiehuo Granules of traditional Chinese Medicine
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal needlesOther
Disposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days.
Ziyinxiehuo Granules of traditional Chinese MedicineDrug
Also called traditional Chinese Medicine for nourishing Yin and purging fire
Ziyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine+acupuncture | Experimental | Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months. Receives: Other: intradermal needles; Drug: Ziyinxiehuo Granules of traditional Chinese Medicine |
| Traditional Chinese Medicine | Active comparator | Subjects in this group will be treated withTraditional Chinese Medicine for 6 months. Receives: Drug: Ziyinxiehuo Granules of traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects' mammary nucleus minification or disappearance at the third month.
The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.
Measured: from baseline to the third month.
Secondary outcomes (1)
the change in bone age／the change in chronological age after six months
The bone age will be measured with X-ray and evaluated with G-P Atlas method at baseline and the sixth month. the change in bone age= bone age after six months-bone age at baseline, the change in chronological age is six months.
Measured: from baseline to the sixth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start15 Sep 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Precocious PubertyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sun Yanyan, Master, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510764
- Sponsor's protocol ID
- 23Y11921100
- Status last verified
- Mar 2026
- First submitted
- 15 Jul 2024
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity
- ClinicalTrials.gov ID
- NCT06510764
- Acronym / sponsor ID
- 23Y11921100
- Conditions
- Precocious Puberty, Treatment, Alternative Medicine, Acupuncture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Sep 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 19 Jul 2024 (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.
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.
Detailed description
Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine+acupuncture | Experimental | Other: intradermal needles, Drug: Ziyinxiehuo Granules of traditional Chinese MedicineSubjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months. |
| Traditional Chinese Medicine | Active comparator | Drug: Ziyinxiehuo Granules of traditional Chinese MedicineSubjects in this group will be treated withTraditional Chinese Medicine for 6 months. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| intradermal needlesDisposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days. | Other | Traditional Chinese Medicine+acupuncture |
| Ziyinxiehuo Granules of traditional Chinese MedicineAlso: traditional Chinese Medicine for nourishing Yin and purging fireZiyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal. | Drug | Traditional Chinese Medicine, Traditional Chinese Medicine+acupuncture |
Primary outcome
The percentage of subjects' mammary nucleus minification or disappearance at the third month.
Time frame: from baseline to the third month.
The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.
1 secondary outcome
the change in bone age／the change in chronological age after six months
Time frame: from baseline to the sixth month
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 16 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Precocious Puberty
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Active, not recruitingObservational study
First Observatory of Precocious Puberty.
Puberty, Precocious
RecruitingPhase 4
Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
Puberty Changes
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Active, not recruitingPhase 3
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
Central Precocious Puberty
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.
Sun Yanyan, Master principal investigator
Children's Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intradermal needles and Ziyinxiehuo Granules of traditional Chinese Medicine in people with Precocious Puberty and Treatment, run by Children's Hospital of Fudan University at 2 sites 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 4 inclusion and 4 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Han Xinghui, Master (021-64931219, 1055952886@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of subjects' mammary nucleus minification or disappearance at the third month. (time frame: from baseline to the third month.). 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 16 Mar 2026.