precocious puberty
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) The child meets the diagnostic criteria of western medicine for precocious puberty (premature Thelarche or idiopathic central precocious puberty); (2) The child meets the diagnostic criteria of liver depression and fire, and needs to have any two accompanying symptoms or signs; (3) Children are only girls, aged =4 years and =10 years; (4) The child has not received any treatment before, which is consistent with the first diagnosis; (5) The children themselves and their legal guardians have informed consent and cooperated with this study.
Exclusion criteria
Exclusion criteria: (1) The child has menarche; (2) Peripheral precocious puberty; (3) Incomplete precocious puberty except Premature Thelarche; (4) Central precocious puberty caused by primary hypothyroidism; (5) Central precocious puberty caused by organic diseases of the central nervous system, such as hypothalamic and pituitary tumors, hamartoma, hydrocephalus and trauma; (6) TCM diagnosis of precocious puberty (liver depression and fire) and other syndromes; (7) Accompanied by serious diseases of heart, kidney, liver and hematopoietic system; (8) Those who are highly allergic or allergic to the drugs in this study; (9) Those who have recently participated in other clinical trials and affected the judgment of curative effect or have recently used sex hormone drugs or traditional Chinese medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction ratio of breast development (Premature Thelarche);Conversion ratio of central precocious puberty (Premature Thelarche);Delayed proportion of sexual development stages (central precocious puberty);Proportion of delayed bone age (central precocious puberty);Predicted as the proportion of height increase at the end of the year (central precocious puberty);Proportion of adverse events (Premature Thelarche, central precocious puberty); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormone six (Premature Thelarche, central precocious puberty);GnRH excitation test (Premature Thelarche, central precocious puberty);Uterine length (Premature Thelarche, central precocious puberty);Ovarian volume (Premature Thelarche, central precocious puberty);Follicle number (Premature Thelarche, central precocious puberty);Maximum diameter of follicle (Premature Thelarche, central precocious puberty);TCM syndrome score (Premature Thelarche, central precocious puberty);growth rate (Premature Thelarche, central precocious puberty);routine blood test (Premature Thelarche, central precocious puberty);Urine routine (Premature Thelarche, central precocious puberty);Then routine (Premature Thelarche, central precocious puberty);Liver and kidney function (Premature Thelarche, central precocious puberty);Thyroid function (Premature Thelarche, central precocious puberty);VitD (Premature Thelarche, central precocious puberty);electrocardiogram (Premature Thelarche, central precocious puberty);CBCL psychological assessment scale;Height standard deviation (HT-SDS);Insulin like growth factor -1 (IGF-1);Insulin Like Growth Factor Binding Protein 3 (IGFBP-3); | — |
Countries
China
Contacts
Hubei Provincial Hospital of Traditional Chinese Medicine (Affiliated Hospital of Hubei University of Traditional Chinese Medicine)