Study on the clinical effect of Zhibai Fuxia decoction combined with rhGH on prediction of adult height in children with precocious puberty

Phase 1

• Conditions: Precocious Puberty

• Registration Number: ITMCTR2000003579
• Lead Sponsor: Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Those who met the diagnostic criteria of peripheral precocious puberty, had abnormal sex hormone, B-ultrasound and X-ray examination, but the sex hormone provocation test did not meet the diagnosis of true precocious puberty;
(2) In addition to the main symptoms, it was accompanied by five heart trouble, hot flushes, fear of heat, red cheekbones, night sweats, irritability and irritability, dry throat and dry mouth, short yellow urine, dry stool, or no moss and thin pulse.
(3) The age of onset was less than 8 years in girls and 9 years in boys;
(4) Girls have not menarche, and their bone age is less than 11 years old or (bone age age age) < 2 years old; boys have no ejaculation and their bone age is less than 13 years old;
(5) Those who sign informed consent.

Exclusion Criteria

(1) True precocious puberty caused by intracranial organic lesions;
(2) Pseudoprecocious puberty, including adrenal or ovarian tumors, fibrous dysplasia associated with precocious puberty syndrome, ingestion of Estrogen;
(3) Precocious puberty of the opposite sex;
(4) Tanner IV and with menses;
(5) Previous history of mental illness or severe heart, brain or neurological disorder.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
labia coloration;pulse;Serum sex hormones;Vaginal discharge;weight;Size of breast and areola;Size of mastoid nucleus;coating on the tongue;Growth of pubic and axillary hairs;height;Growth rate of height;Bone age and predicted height;BMI;TCM syndrome score;Volume measurement of uterus and ovary;Serum ALT, BUN, Cr;