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| Name | Class |
|---|---|
| Shanghai Children's Hospital | OTHER |
| Shanghai Children's Medical Center | OTHER |
| Xin Hua Hospital of Zhejiang Province | OTHER |
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This is a prospective, multicentric, comparative, non-randomized interventional study in which subjects diagnosed with central precocious puberty (CPP) and early puberty (EP) were treated for 6 months to compare the effect with GnRHa and traditional Chinese medicines.
740 girls with CPP and EP participated in this study, all participates were divided into GnRHa group, traditional chinese medicines group and blank group. After at least six months therapy with GnRHa or traditional Chinese medicines, the investigators compare clinical parameters, sex hormone, bone age and ovarian ultrasound in three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GnRHa(Triptorlin or Leuprorelin) | Experimental | Triptorlin or Leuprelin 100ug/kg per 28 days |
|
| Traditional Chinese Medicines | Active Comparator | Zhibo dihuang pills: 8 tablets twice a day by mouth for 6 months and Dabu ying pills: 6g twice a day by mouth for 6 months |
|
| blank group | No Intervention | without therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorlin or Leuprorelin | Drug | Gonadotrophin releasing hormone agonists (GnRHa) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of the height SDS'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of height SDS in the GnRHa group (n=202) is lower than in the traditional chinese medicines group (n=155) ,(P<0.05). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of the breast stages'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of breast stages in the GnRHa group (n=181) is lower than in the traditional chinese medicines group (n=148) ,(P<0.05). | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Comparisons of the BA/CA ratio'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of BA/CA ratio in the GnRHa group (n=152) is lower than in the traditional chinese medicines group (n=86) ,(P<0.05). | 6 months |
| Comparisons of the sex hormone'changes between GnRHa group and traditional chinese medicines group in 6 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pin Li, Dr | Shanghai Children's Hospital | Principal Investigator |
| Xuefan Gu, Dr | Xin Hua Hospital of Zhejiang Province | Principal Investigator |
| Xiaodong Huang, Dr | Shanghai children's medicial Center | Principal Investigator |
| Fan Jiang, Dr | Shanghai children's medicial Center | Principal Investigator |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Zhibo dihuang pills | Drug | Traditional Chinese Medicine |
|
| Dabu ying pills | Drug | Traditional Chinese Medicine |
|
The change levels of sex hormone(LH,FSH and E2) in the GnRHa group (n=164) is lower than in the traditional chinese medicines group (n=94) ,(P<0.05). |
| 6 months |
| Comparisons of the uterine volume'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of uterine volume in the GnRHa group (n=157) is lower than in the traditional chinese medicines group (n=91) ,(P<0.05). | 6 months |
| Comparisons of the ovarian volume'changes between GnRHa group and traditional chinese medicines group in 6 months. | The change levels of ovarian volume in the GnRHa group (n=152) is lower than in the traditional chinese medicines group (n=88) ,(P<0.05). | 6 months |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |