NCT07141615终止不适用
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- breast nucleus diameter
研究概览
简要总结
Clinical Observation of Qingwei Huazhuo Decoction (Product: Jinsaiyu) in Improving Children With Precocious Puberty of Phlegm-Dampness Internal Accumulation Type
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 8 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Experimental
The intervention group is administered Qingwei Huazhuo Decoction therapy and diet and exercise education for a period of six months.
干预措施: 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)
Intervention group
Experimental
The intervention group is administered Qingwei Huazhuo Decoction therapy and diet and exercise education for a period of six months.
干预措施: diet and exercise education (Behavioral)
Control group
Experimental
diet and exercise education
干预措施: diet and exercise education (Behavioral)
结局指标
主要结局
breast nucleus diameter
时间窗: 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
次要结局
- 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.)
研究者
Sunwen
Chief Physician
Children's Hospital of Fudan University
研究点 (1)
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