About this trial
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years;
Tanner stages of breast in female patients ≤ Tanner III stage, diameters 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 less than 1 year and the bone age <10 years old;
No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time.
Disqualifiers
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 design
Parallel
Treatments tested in this trial
intradermal needles
Other interventionDisposable intradermal needles will be used for acupoint stimulation and Tai Chong, Taixi, Sanyinjiao, Hegu as well as Yanglingquan are chosen for acupuncture point. Acupuncture point pressure will last for 10 minutes each time, three times per day, and the intradermal needles will be changed every 2 days.
Ziyinxiehuo Granules of traditional Chinese Medicine
DrugZiyinxiehuo Granules of traditional Chinese Medicine which includes shengdi 15g, xuanshen 9g, zexie 9g, zhimu9g, huangbai 9g, zhiguiban 9g, maiya 15g, tiandong 9g, zhigancao 9g,and will be administered after dissolved, 1package every time, 2 times per day after a meal.
Treatment groups
Trial outcomes
Primary outcomes
The percentage of subjects' mammary nucleus minification or disappearance at the third month.
The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.
Secondary outcomes
the change in bone age/the change in chronological age after six months
The bone age will be measured with X-ray and evaluated with G-P Atlas method at baseline and the sixth month. the change in bone age= bone age after six months-bone age at baseline, the change in chronological age is six months.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.