Precocious Puberty
Conditions
Keywords
precocious puberty, Qingwei Huazhuo Decoction
Brief summary
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
Interventions
COMBINATION_PRODUCTQingwei Huazhuo Decoction: Mulberry leaf powder, lotus leaf powder, malt powder, hawthorn powder, Poria cocos powder, gardenia powder, dried tangerine peel powder, licorice powder, momordica grosvenor
On the basis of receiving dietary and exercise education, the pediatric patients were given the Qingwei Huazhuo Decoction orally. Composition:Mulberry Leaf Powder, Lotus Leaf Powder, Germinated Barley Powder, Hawthorn Powder, Poria Mushroom Powder, Cape Jasmine Fruit Powder, Tangerine Peel Powder, Licorice Root Powder, Monk Fruit Powder. Administration Method:Take one sachet each time, add 150ml of warm boiled water, stir well, and drink. Treatment Course:The first-stage course lasts for 12 weeks.For participants in the experimental group who have completed the first 12-week stage, they may continue to take the Qingwei Huazhuo Decoction orally for another 12 weeks
BEHAVIORALdiet and exercise education
① Dietary Education With reference to the Balanced Diet Pagoda for School-Age Children Aged 6-10 Years in the Chinese Dietary Guidelines for School-Age Children (2022), the children were required to record their daily diet and complete a dietary diary. ② Exercise Education Children were advised to accumulate at least 60 minutes of moderate-to-vigorous physical activity (MVPA) daily, mainly consisting of aerobic exercise. The specific requirements were as follows: 1.3-5 sessions of aerobic exercise per week; 2.2-3 sessions of resistance exercise per week; 3.Daily screen time limited to less than 2 hours. The parents were asked to record their children's daily completion of the above requirements.
Sponsors
Children's Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
5 Years to 8 Years
Healthy volunteers
No
Inclusion criteria
* 1\. With reference to the diagnostic criteria for incomplete precocious puberty (isolated premature thelarche) in \*Expert Consensus on the Diagnosis and Treatment of Central Precocious Puberty (2022)\* and \*Modern Pediatrics Diagnosis and Treatment\*, the following requirements must be met: (1) Female children with initial symptoms of unilateral or bilateral breast development, without other signs of sexual development; (2) No accelerated growth and bone age not exceeding the actual age by 1 year; (3) No vaginal bleeding; (4) Plasma estradiol (E2) and follicle-stimulating hormone (FSH) levels within the reference range or slightly elevated. * 2\. Based on the doctor's clinical judgment, the traditional Chinese medicine (TCM) syndrome type conforms to the diagnostic criteria for phlegm-dampness internal accumulation syndrome. With reference to the syndrome classification criteria in \*Guidelines for Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Pediatric Precocious Puberty (2023 Edition)\*, the diagnosis can be made if the child meets 2-3 or more symptoms of any syndrome type, and the tongue and pulse conditions are basically consistent with the syndrome. Details of the syndrome are as follows: Phlegm-dampness internal accumulation: The child has premature appearance of secondary sexual characteristics, which may be accompanied by excessive consumption of fatty and sweet foods, obesity, heavy sensation in limbs, being quiet and inactive, sticky sensation in the mouth, red tongue with thick and greasy coating, and slippery and rapid pulse. * 3\. Obtain the informed consent form signed by the legal guardian of the subject.
Exclusion criteria
* 1\. Children with peripheral precocious puberty or central precocious puberty (idiopathic and secondary); * 2\. Children with other severe underlying diseases, including but not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidneys, liver, gastrointestinal tract, respiratory system, metabolic system, and skeletal system; * 3\. Those allergic to any component of Qingwei Huazhuo Recipe (Product: Jinsaiyu); * 4\. Those currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months; * 5\. Children judged by researchers to have poor compliance and are not suitable for entering this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| breast nucleus diameter | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. | Measured by the attending physician using a straightedge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bone age | The measurement times are before the start of the experiment and the 24th week after the start. | Bone age is determined by radiologists in our hospital who take a posteroanterior radiograph of the left hand and judge the bone age according to the Greulich-Pyle (GP) atlas method. |
| Traditional Chinese Medicine syndrome score | The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start. | According to the Guidelines for the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Pediatric Precocious Puberty (2023 Edition) and clinical experience, the scoring criteria for traditional Chinese medicine (TCM) syndromes were screened and determined: each symptom was assigned a score: 0 for no symptom; 1 for mild; 2 for moderate; 3 for severe. The total score was obtained by summing the scores of all symptoms. |
Contacts
CONTACTWen Sun, Doctor
CONTACTTeng Fan
Outcome results
None listed