Indicators and Evaluation of Efficacy of Yin-nourishing and Fire-reducing Chinese Medicine for Girls With Rapid Progression of Early Puberty
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence of rapid progression type of precocious puberty
研究概览
简要总结
- Evaluate whether AMH and SHBG have differential expression before and after the diagnosis of rapid and slow progression types of early puberty and whether this difference has a predictive effect on the rapid progression type. 2. Assess the therapeutic effect of nourishing yin and purging fire traditional Chinese medicine on girls with rapid progression type of early puberty providing a standardized clinical basis for the formulation of diagnostic and treatment guidelines (or protocols) for the rapid progression type of early puberty using traditional Chinese medicine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
In this study, 80 patients with premature puberty are included by simple randomization. The randomization scheme is generated by an independent statistical team from the Clinical Trial Center of Children's Hospital of Fudan University using SAS 9.4 software. The intervention protocol determined by the random allocation sequence will be managed by a central coordinator who is not involved in the implementation of the intervention or outcome assessment. The central coordinator will inform the researchers involved in the study of the allocation scheme for the study subjects in accordance with the order in which the guardians of the study subjects sign the informed consent form. The doctor in charge of outcome assessment is completely unaware of the group assignment of the study subjects.
入排标准
- 年龄范围
- 8 Years 至 9 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls with an onset age >8 years and ≤9 years;
- •Breast bud Tanner stage II breast bud diameter <3 cm;
- •Ultrasound examination: unilateral ovarian volume ≥1-3 ml and/or follicle diameter ≥4 mm;
- •Bone age does not exceed actual age by more than 1 year;
- •LHRH stimulation test: LH/FSH ≥0.6 LH peak ≥5.0 IU/L.
- •Good compliance;
- •Patients and their parents are willing to actively cooperate with the clinical trial;
- •Legal guardian signs the informed consent form.
排除标准
- •Disorders of gonadal development such as chromosomal abnormalities hypospadias intersex conditions etc.;
- •Use of treatments that affect gonadal function such as chemotherapy radiotherapy;
- •Diabetes thyroid dysfunction obesity lipid metabolism disorders or other congenital diseases.
研究组 & 干预措施
Intervention group
The intervention group is administered drug therapy for a period of six months.
干预措施: Xuandi Ziyin Mixture (Drug)
结局指标
主要结局
The incidence of rapid progression type of precocious puberty
时间窗: From enrollment to 6 months after treatment.
The incidence of rapid progression type of precocious puberty between two groups.
次要结局
- AMH(From enrollment to 6 months after treatment.)
- SHBG(From enrollment to 6 months after treatment.)