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

NCT07141615 | Terminated

• 1 other identifier: FDCH-ZY-2025162
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Precocious Puberty

Keywords

precocious puberty; Qingwei Huazhuo Decoction

Outcome Measures

Primary Outcomes (1)

• breast nucleus diameter

  Measured by the attending physician using a straightedge

  The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.

Secondary Outcomes (2)

• Bone age

  The measurement times are before the start of the experiment and the 24th week after the start.

• 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.

Other Outcomes (18)

• Testosterone

  The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.

• PRL

  The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.

• Estradiol

  The measurement times are before the start of the experiment, the 12th week after the start, and the 24th week after the start.

Study Arms (2)

Intervention group

EXPERIMENTAL

The intervention group is administered Qingwei Huazhuo Decoction therapy and diet and exercise education for a period of six months.

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; Behavioral: diet and exercise education

Control group

EXPERIMENTAL

diet and exercise education

Behavioral: diet and exercise education

Interventions

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 COMBINATION_PRODUCT

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

Intervention group

diet and exercise education BEHAVIORAL

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.

Control group; Intervention group

Eligibility Criteria

• Age: 5 Years - 8 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \. 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.
• \. 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.
• \. Obtain the informed consent form signed by the legal guardian of the subject.

You may not qualify if:

• \. Children with peripheral precocious puberty or central precocious puberty (idiopathic and secondary);
• \. 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;
• \. Those allergic to any component of Qingwei Huazhuo Recipe (Product: Jinsaiyu);
• \. Those currently participating in other clinical trials or who have participated in other clinical trials within the past 3 months;
• \. Children judged by researchers to have poor compliance and are not suitable for entering this study.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Diet

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: August 19, 2025
• First Posted: August 26, 2025
• Study Start: March 30, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)