The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea
2026年5月5日 更新者：Peking Union Medical College Hospital
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.
研究概览
研究类型
介入性
注册 (估计的)
210
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Yan Deng, Doctor
- 电话号码：86+010-69158331
- 邮箱：yanndeng@163.com
学习地点
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-
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Beijing、中国、100730
- 招聘中
- Peking Union Medical College Hospital
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接触：
- Yan Deng, Doctor
- 电话号码：01069158331
- 邮箱：yanndeng@163.com
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首席研究员：
- Aijun Sun, Doctor
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
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
Exclusion Criteria:
- 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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
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Western medicine（Femoston 2/10)
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实验性的：Ba Zhen Yi Mu Pill and Ding Kun Dan group
Participants received Traditional Chinese medicine Ba Zhen Yi Mu Pill (6g three times daily) and Ding Kun Dan (7g twice daily) concurrently.
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traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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实验性的：Ba Zhen Yi Mu Pill and Ding Kun Dan combined with Femoston group
Participants in the intervention group received Ba Zhen Yi Mu Pill (6 g twice daily), Ding Kun Dan (7g twice daily), and Femoston (estradiol 2mg / dydrogesterone 10mg, 1 tablet daily) concurrently.
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Western medicine（Femoston 2/10)
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Menstrual patterns during treatment and after discontinuation
大体时间：From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Document the number of episodes of menstruation during the treatment and follow-up period
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From enrollment, during the treatment of 6 months, and within 3 months after treatment
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Sex hormone levels
大体时间：from enrollment to the end of treatment at 6 months
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Measure the levels of sex hormones in the blood, including Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Estradiol (E2), Progesterone (P), Prolactin (PRL), Dehydroepiandrosterone Sulfate (DHEA-S), and Anti-Müllerian Hormone (AMH).
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from enrollment to the end of treatment at 6 months
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Uterine volume
大体时间：From enrollment to the end of treatment at 6 months
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Uterine volume was calculated using the length, width, and anteroposterior diameter measured by ultrasound, according to the formula Volume = 0.5233 × L × W × AP, where L, W, and AP represent the length, width, and anteroposterior diameter of the uterus measured by ultrasound.
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From enrollment to the end of treatment at 6 months
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Quality of Life Score(36-Item Short Form Health Survey，SF 36)
大体时间：From enrollment to the end of treatment at 6 months
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The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
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From enrollment to the end of treatment at 6 months
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Total ovarian volume
大体时间：from enrollment to the end of treatment at 6 months
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Total ovarian volume (cm³) was calculated by summing the volumes of the left and right ovaries, each of which was derived using the ellipsoid formula: V = 0.523 × length × width × thickness .The three perpendicular diameters of the ovary (length, width, and thickness) were measured using ultrasound.
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from enrollment to the end of treatment at 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
大体时间：From enrollment to 3 months after the end of treatment
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Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II).
Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms (worse outcome).
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From enrollment to 3 months after the end of treatment
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
大体时间：From enrollment to 3 months after the end of treatment
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Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms (worse outcome).
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From enrollment to 3 months after the end of treatment
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Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
大体时间：From enrollment to 3 months after the end of treatment
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Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10).
Total scores range from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
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From enrollment to 3 months after the end of treatment
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Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26)
大体时间：From enrollment to 3 months after the end of treatment
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Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) .
Total scores range from 0 to 78 , with higher scores indicating more disordered eating pathology (worse outcome) .
A score of 20 or higher is considered indicative of an elevated risk for an eating disorder, warranting further clinical evaluation
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From enrollment to 3 months after the end of treatment
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
大体时间：From enrollment to the end of treatment at 6 months
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Participants were followed up at the hospital every 3 months during the treatment period.
At each follow-up visit, adverse events (AEs) were documented, and their causality (relationship to the treatment) was assessed by the investigators.
The severity of AEs was graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
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From enrollment to the end of treatment at 6 months
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
大体时间：From enrollment to 3 months after the end of treatment.
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Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Elevated ALT levels indicate hepatocellular injury (worse outcome).
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From enrollment to 3 months after the end of treatment.
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Renal function was assessed by measuring serum creatinine (SCr) levels
大体时间：From enrollment to 3 months after the end of treatment
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Renal function was assessed by measuring serum creatinine (SCr) levels.
Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .
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From enrollment to 3 months after the end of treatment
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Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
大体时间：From enrollment to 3 months after the end of treatment
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Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
Total physical activity was calculated as metabolic equivalent of task (MET)-minutes per week, ranging from 0 to 14,280 MET-minutes/week (theoretical maximum), with higher scores indicating greater physical activity levels (better outcome) .
Total sitting time was recorded as minutes per week, ranging from 0 to 1,440 minutes/week, with higher scores indicating more sedentary behavior (worse outcome) .
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From enrollment to 3 months after the end of treatment
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年10月22日
初级完成 (估计的)
2028年6月30日
研究完成 (估计的)
2028年6月30日
研究注册日期
首次提交
2026年4月27日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月12日
研究记录更新
最后更新发布 (实际的)
2026年5月12日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2025年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.