The Research of Integrated Traditional Chinese and Western Medicine on Hypothalamic Amenorrhea

Обзор

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.

Вмешательства

• Препарат traditional Chinese medicine
  traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
• Препарат Western medicine
  Western medicine（Femoston 2/10)

Первичные конечные точки

• Menstrual patterns during treatment and after discontinuation [Срок оценки: From enrollment, during the treatment of 6 months, and within 3 months after treatment]
• Sex hormone levels [Срок оценки: from enrollment to the end of treatment at 6 months]
• Uterine volume [Срок оценки: From enrollment to the end of treatment at 6 months]
• Quality of Life Score(36-Item Short Form Health Survey，SF 36) [Срок оценки: From enrollment to the end of treatment at 6 months]
• Total ovarian volume [Срок оценки: from enrollment to the end of treatment at 6 months]

Вторичные конечные точки (4)

• Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II) [Срок оценки: From enrollment to 3 months after the end of treatment]
• Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale. [Срок оценки: From enrollment to 3 months after the end of treatment]
• Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10) [Срок оценки: From enrollment to 3 months after the end of treatment]
• Disordered eating attitudes and behaviors were assessed using the 26-item Eating Attitudes Test (EAT-26) [Срок оценки: From enrollment to 3 months after the end of treatment]

Критерии участия

Критерии включения

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

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07580950 · 2025YFC3508004 · 2025YFC3508004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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