NCT07141615

Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 5 Years – 8 Years
• Healthy volunteers: Not accepted

Summary

Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type

Conditions

• Precocious Puberty

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Qingwei 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
BEHAVIORAL	diet 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.

Timeline

• Start date: 2026-03-30
• Primary completion: 2027-11-16
• Completion: 2027-12-16
• First posted: 2025-08-26
• Last updated: 2026-03-19