Precocious PubertyNCT02650141
Clinical Trial of Experienced Chinese Herbal Formulas on Different Types of Precocious Puberty
A study testing ziyinxiehuo Granules and zishenqinggan Granules in people with Precocious Puberty, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease. Read more about this study
- Who is it for?
- Ages Up to 8 years, women only
- Conditions the study is for
- Precocious Puberty
- What is being tested?
- ziyinxiehuo Granules and zishenqinggan Granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Apr 2016
- Phase
- Interventional
- 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 Up to 8 years
- Women only
- No healthy volunteers
- Child
Who may be able to join
- Girls are diagnosed as simple early breast development, and their age of onset is less than 8 years
- Tanner stages of breast in female patients are Tanner II and Tanner III, Diameter of mammary nucleus is less than 3cm；
- B-type ultrasonography: the size and volume of uterus and follicle is in the normal range at the same age；
- bone age: the bone age in the patients are the same with their actual age.
- Girls are diagnosed as Idiopathic central precocious puberty，and their age of onset ≤8 years
- Tanner stages of brest in female patients ≤ Tanner III stage，diameter of mammillary nucleus < 3cm
Show all 10Show fewer
- B-type ultrasonography: the volume of uterus≥1~3ml，the diameter of follicle≥4mm;or the length of uterus ≥3.4-4cm
- bone age: compared the actual age ,the bone age is no more than 1 year and the bone age <10 years old;
- in master single test: LH >3 IU/L
- GnRH stimulation test: LH/FSH>0.6, the Peak LH 3.5~5.0 IU/L, the Peak LH 3.5~5.0 IU/L.
Who cannot join
- the bone age is advanced by more than 1 standard deviations for chronological age
- pseudo sexual precocity, including gonadal tumor,adrenal disease,exogenous intake induced with hormone drugs or food and multiple bone fiber structure dysplasia of precocious puberty (McCune Albright syndrome)
- heterosexual precocious puberty
- In the mild true precocious puberty children：
- The central nervous system organic diseases caused sexual precocity
- congenital thyroid function reduce disease with precocious puberty, congenital adrenal hyperplasia, adrenal tumor
Show all 10Show fewer
- ovarian or testicular neoplasms,
- McCune Albright syndrome (precocious puberty with polyostotic fibrous dysplasia and skin pigment abnormalities, pigmentation)
- there is a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematosus, etc
- precocious puberty and partial precocious puberty
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Chinses Traditional Medcine； Children Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease.
Read the detailed description
In the research, 138 precocious puberty children are randomly divided into the Ziyinxiehuo granules group (69 cases) and Zishenqinggan granules group(69 cases). Patients in Ziyinxiehuo granules group are treated with a series of experienced chinese herbal formulas, whereas the Zishenqinggan granules group received with different series of experienced chinese herbal formulas.
- Conditions
- Precocious Puberty
- Being tested
- ziyinxiehuo Granules, zishenqinggan Granules
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziyinxiehuo GranulesDrug
Also called nourishing"Yin"-removing"Fire" Granules
Ziyinxiehuo granules Herbs (1 bag ): shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g Therapeutic Principle: Nourishing "Yin", removing "Fire" Usage: administered after dissolved, 3 times per day after breakfast and supper
zishenqinggan GranulesDrug
Also called replenishing "Kidney"-Clearing "Liver" Granules
Zishenqinggan granules Herbs (1 bag ): Shengdi 5g, baishao 3g, huangqin 3g, fuling 4g, danpi 3g, maiya 6g, shanzha 3g, zhebei 3g, zhigancao 2g Therapeutic Principle: replenishing "Kidney", Clearing "Liver" Usage: administered after dissolved, 3 times per day after breakfast and supper
| Study group | Role | What they receive |
|---|---|---|
| ziyinxiehuo Granules | Experimental | Children of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months. Receives: Drug: ziyinxiehuo Granules |
| zishenqinggan Granules | Active comparator | Children of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months. Receives: Drug: zishenqinggan Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in some index of B type ultrasonography ( uterus,ovary,follicle )
The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )
Measured: 3 months, 6months
Secondary outcomes (2)
change in the mammary nucleus index
The investigators will measure the change of the mammary nucleus index by the mammary diameter
Measured: 3 months, 6 months
change in the cumulative score of traditional Chinese medicine syndromes
The investigators will measure the change in scores of chinese medicine symptoms according to the Traditional Chinese Medicine Guideline Scale: 0 - 3. 0 = None. 1 = Mild. 2 = Moderate. 3= Severe
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2016 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 143 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 Y Jian, professor, Study chair, Children Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02650141
- Sponsor's protocol ID
- NO.12401905505
- Status last verified
- Nov 2019
- First submitted
- 4 Jan 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: The data will be used by the research group only.
Publications
Sun W, Han X, Wang Y, Yu J, Yan W, Zhao J, Chen W, Xue Z. Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial. J Tradit Chin Med. 2018 Oct;38(5):740-745.
PubMed 32185991
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Experienced Chinese Herbal Formulas for the Treatment of Different Types of Precocious Puberty: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02650141
- Acronym / sponsor ID
- NO.12401905505
- Conditions
- Precocious Puberty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Jan 2016 (estimated)
- 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.
Due to various complex factors, the incidence of precocious puberty is increasing rapidly. It severely threatens physical and mental health of children. It's urgent to explore effective ways to control the disease.
Detailed description
In the research, 138 precocious puberty children are randomly divided into the Ziyinxiehuo granules group (69 cases) and Zishenqinggan granules group(69 cases). Patients in Ziyinxiehuo granules group are treated with a series of experienced chinese herbal formulas, whereas the Zishenqinggan granules group received with different series of experienced chinese herbal formulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ziyinxiehuo Granules | Experimental | Drug: ziyinxiehuo GranulesChildren of ziyinxiehuo granules group will be treated with chinese herbal granules,3 times a day, for 6 months. |
| zishenqinggan Granules | Active comparator | Drug: zishenqinggan GranulesChildren of zishenqinggan granules group will be treated with chinese herbal granules, 3 times a day, for 6 months. |
Who may qualify
- Ages
- Up to 8 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Girls are diagnosed as Idiopathic central precocious puberty，and their age of onset ≤8 years
- Tanner stages of brest in female patients ≤ Tanner III stage，diameter of mammillary nucleus < 3cm
- B-type ultrasonography: the volume of uterus≥1~3ml，the diameter of follicle≥4mm;or the length of uterus ≥3.4-4cm
- bone age: compared the actual age ,the bone age is no more than 1 year and the bone age <10 years old;
- in master single test: LH >3 IU/L
Key exclusion criteria (10 listed)
- In the mild true precocious puberty children：
- The central nervous system organic diseases caused sexual precocity
- congenital thyroid function reduce disease with precocious puberty, congenital adrenal hyperplasia, adrenal tumor
- ovarian or testicular neoplasms,
- McCune Albright syndrome (precocious puberty with polyostotic fibrous dysplasia and skin pigment abnormalities, pigmentation)
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 GranulesAlso: nourishing"Yin"-removing"Fire" GranulesZiyinxiehuo granules Herbs (1 bag ): shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g Therapeutic Principle: Nourishing "Yin", removing "Fire" Usage: administered after dissolved, 3 times per day after breakfast and supper | Drug | ziyinxiehuo Granules |
| zishenqinggan GranulesAlso: replenishing "Kidney"-Clearing "Liver" GranulesZishenqinggan granules Herbs (1 bag ): Shengdi 5g, baishao 3g, huangqin 3g, fuling 4g, danpi 3g, maiya 6g, shanzha 3g, zhebei 3g, zhigancao 2g Therapeutic Principle: replenishing "Kidney", Clearing "Liver" Usage: administered after dissolved, 3 times per day after breakfast and supper | Drug | zishenqinggan Granules |
Primary outcome
Change in some index of B type ultrasonography ( uterus,ovary,follicle )
Time frame: 3 months, 6months
The investigators will measure the change of some index of B type ultrasonography ( the volume of uterus and ovary, the biggest follicle diameter )
2 secondary outcomes
change in the mammary nucleus index
Time frame: 3 months, 6 months
change in the cumulative score of traditional Chinese medicine syndromes
Time frame: 3 months, 6 months
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 3 Dec 2019.
- Results publication: PubMed 32185991Sun W, Han X, Wang Y, Yu J, Yan W, Zhao J, Chen W, Xue Z. Effectiveness of ZiYin Xiehuo granules and Zishen Qinggan granules on partial precocious puberty in girls: a multicenter, randomized, single-blind, controlled trial. J Tradit Chin Med. 2018 Oct;38(5):740-745.
- Individual participant dataSharing planned: No. The data will be used by the research group only.
Related trials for Precocious Puberty
RecruitingObservational study
Natural History Study of Patients With Excess Androgen
Congenital Adrenal Hyperplasia (CAH), Familial Male-Limited Precocious Puberty (FMPP)
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. This study is not recruiting at the moment.
Jian Y Jian, professor study chair
Children 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 study testing ziyinxiehuo Granules and zishenqinggan Granules in people with 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 10 inclusion and 10 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 3 Dec 2019. 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.
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?
Change in some index of B type ultrasonography ( uterus,ovary,follicle ) (time frame: 3 months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02650141, which also lists 1 linked publication.
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 3 Dec 2019.