NCT07580950招募中4 期
The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 1
研究概览
简要总结
This study aims to validate the efficacy and safety of the "two-step cycle-regulating approach integrating Chinese and Western medicine: rapid restoration of menstruation with Western medicine, and nourish the kidney and soothe the liver, nourishing the essence, and reinforcing the vital essence and strengthening the primordial qi with Chinese medicine" through a nationwide randomized controlled clinical trial involving 210 cases. Guided by traditional Chinese medicine theory, the study will explore the mechanism of integrated Chinese and Western medicine in the treatment of functional hypothalamic amenorrhea through gut microbiota and metabolomics research.
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
- None
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnostic criteria for functional hypothalamic amenorrhea
- •primary or secondary amenorrhea
- •Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL
- •Exclusion of amenorrhea caused by: -Organic lesions of the hypothalamus or pituitary gland , Ovarian amenorrhea , Uterine or lower genital tract developmental abnormalities ,Drug-induced amenorrhea ,Other causes of amenorrhea
排除标准
- •Individuals who have used relevant medications within the past 3 months
- •History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
- •Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
- •Lactating or pregnant women, or females within one year postpartum
- •History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
- •Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
- •History of thromboembolic disease or thrombotic tendency.
- •Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).
研究者
研究点 (1)
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