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

NCT07141615 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-05-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Children's Hospital of Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
8 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07141615 on ClinicalTrials.gov