A Randomized Controlled Trial of Ziyin-Xiehuo Chinese Medicine Herbs Combined With Intradermal Acupuncture for the Treatment of Girl's Idiopathic Precocious Puberty With Yin Deficiency and Fire Hyperactivity
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- The percentage of subjects' mammary nucleus minification or disappearance at the third month.
研究概览
简要总结
A randomized controlled study will be conducted to evaluate the therapeutic effect of traditional Chinese medicine and acupoints stimulation on children with idiopathic precocious puberty.
详细描述
Traditional Chinese medicine is effective for precocious puberty which is mild or moderate, but not effective for the one that is severe and rapidly progressing. Acupuncture can effectively regulate sex hormone levels and ovarian function, promote ovulation, and have therapeutic effect for polycystic ovary syndrome and irregular menstruation. Studies have shown that acupuncture and auricular point compression stimulation is effective for premature thelarche, yet there are few studies on idiopathic precocious puberty. Clinical evidence is still needed to support whether acupuncture point stimulation combined with traditional Chinese Medicine herbs can enhance the effect and prevent the progression into severe or rapidly progressing precocious puberty, hence the study is to be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 4 Years 至 9 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Girls are diagnosed as Idiopathic precocious puberty, and their age of onset ≤7.5years;
- •Tanner stages of breast in female patients ≤ Tanner III stage, diameters of mammillary nucleus ≤ 3cm; •B-type ultrasonography: the volume of uterus≥ 3ml, the volume of ovary≥1.5ml, the diameter of follicle≥4mm;
- •Bone age: compared the chronological age, the bone age is less than 1 year and the bone age <10 years old;
- •No GnRH analogs or Sex hormones were administrated in the past; and All above are needed at the same time.
排除标准
- •Precocity caused by the central nervous system organic diseases;
- •Precocious precocity caused by congenital hypothyroidism, congenital adrenal hyperplasia, adrenal tumor and ovarian or testicular neoplasms as well as McCune-Albright syndrome, etc;
- •Precocious precocity with a family history of diseases such as tumor, leukemia, diabetes, systemic lupus erythematous;
- •Pseudo sexual precocity and partial precocious puberty.
研究组 & 干预措施
Traditional Chinese Medicine+acupuncture
Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
干预措施: intradermal needles (Other)
Traditional Chinese Medicine+acupuncture
Subjects in this group will be treated with traditional Chinese medicine and intradermal acupuncture point stimulation for 6 months.
干预措施: Ziyinxiehuo Granules of traditional Chinese Medicine (Drug)
Traditional Chinese Medicine
Subjects in this group will be treated withTraditional Chinese Medicine for 6 months.
干预措施: Ziyinxiehuo Granules of traditional Chinese Medicine (Drug)
结局指标
主要结局
The percentage of subjects' mammary nucleus minification or disappearance at the third month.
时间窗: from baseline to the third month.
The diameters of mammary nucleus will be measured with rulers along the median line of the breast at baseline,the third month and the sixth month. The subject numbers of mammary nucleus minification or disappearance at third month will be recorded. The percentage=the subject numbers of mammary nucleus minification or disappearance /total subject numbers in this group ×100%.
次要结局
- the change in bone age／the change in chronological age after six months(from baseline to the sixth month)