Idiopathic Precocious PubertyPhase 4NCT03963752
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
A Phase 4 study testing Ziyinxiehuo Granules Herbs, Megestrol Acetate Tablet and Leuprorelin Acetate 3.75mg Injection in people with Idiopathic Precocious Puberty, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty. Read more about this study
- Who is it for?
- Ages 5 to 8 years, women only
- Conditions the study is for
- Idiopathic Precocious Puberty
- What is being tested?
- Ziyinxiehuo Granules Herbs, Megestrol Acetate Tablet and Leuprorelin Acetate 3.75mg Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 15 Aug 2019to 30 Sep 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 5 to 8 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;
- Tanner stages of breast in female patients ≥ Tanner III stage，diameter 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 more than 1 year and the bone age <11.5 years old;
- It progresses rapidly, ratio of bone age difference to chronological age difference> 1;
- No GnRH analogs or sex hormones were administrated in the past;
- All above are needed at the same time.
Who cannot join
- Precocious 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
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.
Read the detailed description
In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.
- Conditions
- Idiopathic Precocious Puberty
- Being tested
- Ziyinxiehuo Granules Herbs, Megestrol Acetate Tablet, Leuprorelin Acetate 3.75mg Injection
- Keywords
- Idiopathic Precocious Puberty, Rapid Progressive, Integrative Chinese and Western Medicine, Evidence-based Medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ziyinxiehuo Granules HerbsDrug
Also called nourishing"Yin"-removing"Fire" Granules
1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
Megestrol Acetate TabletDrug
the dose is 6-8mg/d, three times per day after meals.
Leuprorelin Acetate 3.75mg InjectionDrug
Usage： 80μg/kg by subcutaneous injection, every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ziyinxiehuo Granules and Megestrol Acetate | Experimental | Experimental：Group Ziyinxiehuo Granules and Megestrol Acetate Tablet Intervention :Subjects in Group Ziyinxiehuo Granules and megestrol acetate tablet will be treated with Ziyinxiehuo Granules and megestrol acetate tablet for 6 months.1 pack of Ziyinxiehuo granules Herbs includes shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g. Ziyinxiehuo Granules is administered after dissolved,1pack every time, 2 times per day after a meal; and the dosage of megestrol acetate is 6-8mg/d, which is taken in 3 times after a meal. Receives: Drug: Ziyinxiehuo Granules Herbs; Drug: Megestrol Acetate Tablet |
| Gonadotrophin | Active comparator | Active Comparator: Group Gonadotrophin Intervention: Subjects in Group Gonadotrophin will be treated with gonadotrophin releasing hormone agonist for 6months. In our study Leuprorelin Acetate 3.75mg Injection will be applied, the dosage of which is 80μg/kg every time by subcutaneous injection, every 4 weeks for once. Receives: Drug: Leuprorelin Acetate 3.75mg Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
The investigators will measure subjects' mammary nucleus diameter through the midline of the breast with a ruler after six months of continuous treatment, and percentage of the mammary nucleus diameter reduced to less than 1cm in each group will be calculated.
Measured: After six months of continuous treatment
Secondary outcomes (1)
Ratio of bone age difference to chronological age difference
The left hand orthotopic X-ray (including the carpal bone and the lower end of the ulna) will be filmed by the Department of Radiology before and after treatment, and the bone age will be measured according to the Greulich-Pyle map method. Ratio of bone age difference to chronological age difference will be calculated.
Measured: After six months of continuous treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start15 Aug 2019
- Primary completion15 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Yu, Children's Hospital of Fudan University
- Investigators
- Jian Yu, professor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963752
- Sponsor's protocol ID
- 18401902300
- Status last verified
- Feb 2024
- First submitted
- 22 May 2019
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-based Medical Research on the Treatment of Children's Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine
- ClinicalTrials.gov ID
- NCT03963752
- Acronym / sponsor ID
- 18401902300
- Conditions
- Idiopathic Precocious Puberty
- Keywords
- Idiopathic Precocious Puberty, Rapid Progressive, Integrative Chinese and Western Medicine, Evidence-based Medicine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 28 May 2019 (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.
Our study used a randomized controlled trial to validate the clinical efficacy of a combination of traditional Chinese and Western medicine in the treatment of children with rapid progressive central precocious puberty.
Detailed description
In the research, 164 subjects diagnosed with rapid progressive idiopathic precocious puberty are randomly divided into Group Ziyinxiehuo Granules and Megestrol Acetate Tablet（82 cases）and Group Gonadotrophin ( 82 cases). Patients in Group Ziyinxiehuo Granules and Megestrol Acetate Tablet are treated with ziyinxiehuo Granules and megestrol acetate tablet , whereas the Group Gonadotrophin received with gonadotrophin releasing hormone agonist, and all the subjects in two groups are continuously treated for 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ziyinxiehuo Granules and Megestrol Acetate | Experimental | Drug: Ziyinxiehuo Granules Herbs, Drug: Megestrol Acetate TabletExperimental：Group Ziyinxiehuo Granules and Megestrol Acetate Tablet Intervention :Subjects in Group Ziyinxiehuo Granules and megestrol acetate tablet will be treated with Ziyinxiehuo Granules and megestrol acetate tablet for 6 months.1 pack of Ziyinxiehuo granules Herbs includes shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g. Ziyinxiehuo Granules is administered after dissolved,1pack every time, 2 times per day after a meal; and the dosage of megestrol acetate is 6-8mg/d, which is taken in 3 times after a meal. |
| Gonadotrophin | Active comparator | Drug: Leuprorelin Acetate 3.75mg InjectionActive Comparator: Group Gonadotrophin Intervention: Subjects in Group Gonadotrophin will be treated with gonadotrophin releasing hormone agonist for 6months. In our study Leuprorelin Acetate 3.75mg Injection will be applied, the dosage of which is 80μg/kg every time by subcutaneous injection, every 4 weeks for once. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Girls are diagnosed as Idiopathic central precocious puberty by GnRH （gonadotrophin releasing hormone）Stimulation Test, and their age of onset ≤8 years;
- Tanner stages of breast in female patients ≥ Tanner III stage，diameter 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 more than 1 year and the bone age <11.5 years old;
- It progresses rapidly, ratio of bone age difference to chronological age difference> 1;
Key exclusion criteria (4 listed)
- Precocious 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 |
|---|---|---|
| Ziyinxiehuo Granules HerbsAlso: nourishing"Yin"-removing"Fire" Granules1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal. | Drug | Ziyinxiehuo Granules and Megestrol Acetate |
| Megestrol Acetate Tabletthe dose is 6-8mg/d, three times per day after meals. | Drug | Ziyinxiehuo Granules and Megestrol Acetate |
| Leuprorelin Acetate 3.75mg InjectionUsage： 80μg/kg by subcutaneous injection, every 4 weeks | Drug | Gonadotrophin |
Primary outcome
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm
Time frame: After six months of continuous treatment
The investigators will measure subjects' mammary nucleus diameter through the midline of the breast with a ruler after six months of continuous treatment, and percentage of the mammary nucleus diameter reduced to less than 1cm in each group will be calculated.
1 secondary outcome
Ratio of bone age difference to chronological age difference
Time frame: After six months of continuous treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Precocious Puberty
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Idiopathic Central Precocious Puberty and Associated Neurodevelopmental Syndromes and Pathologies: Evaluation of Frequency and Comparison of Diagnostic and Developmental Characteristics
Central Precocious Puberty (CPP)
Not yet recruitingPhase 4
Efficacy, Metabolism and BMD of the 3-month TP Compared to the 1-month TP in ICPP
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. This study is not recruiting at the moment.
Jian Yu, professor study chair
Children's Hospital of Fudan University
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 Ziyinxiehuo Granules Herbs, Megestrol Acetate Tablet and Leuprorelin Acetate 3.75mg Injection in people with Idiopathic Precocious Puberty, 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 7 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: finished, as of the sponsor's last update on 7 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the Mammary Nucleus Diameter reduced to less than 1cm (time frame: After six months of continuous 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 7 Feb 2024.