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

5 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

210

Fase

  • Fase 4

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Yan Deng, Doctor
  • Número de teléfono: 86+010-69158331
  • Correo electrónico: yanndeng@163.com

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana, 100730
        • Reclutamiento
        • Peking Union Medical College Hospital
        • Contacto:
          • Yan Deng, Doctor
          • Número de teléfono: 01069158331
          • Correo electrónico: yanndeng@163.com
        • Investigador principal:
          • Aijun Sun, Doctor

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Niño
  • Adulto

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

Diagnostic criteria for functional hypothalamic amenorrhea

  1. primary or secondary amenorrhea
  2. Normal or low FSH levels, LH < 5 IU/L, E2 < 50 pg/mL
  3. 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:

  1. Individuals who have used relevant medications within the past 3 months
  2. History of substance abuse or dependence (alcohol or drugs) within the past 3 months; heavy smokers (those consuming 20 or more cigarettes daily)
  3. Individuals with severe or unstable physical illnesses, including liver, kidney, gastrointestinal, cardiovascular, cerebrovascular, respiratory, endocrine, neurological, immune, or hematological disorders; psychiatric patients
  4. Lactating or pregnant women, or females within one year postpartum
  5. History of allergy to the investigational drug; contraindications to Dingkundan, Bazhen Yimu Pills, or Femoston
  6. Individuals with or suspected of having estrogen-sensitive tumors (e.g., endometrial cancer, breast cancer).
  7. History of thromboembolic disease or thrombotic tendency.
  8. Participation in another investigational drug clinical trial within 1 month prior to inclusion in this study (first interview).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Femoston group
Femoston 2/10 (estradiol 2mg / dydrogesterone 10mg), 1 tablet daily.
Droga: Western medicine
Western medicine（Femoston 2/10)
Experimental: 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.
Droga: traditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）
Experimental: 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.
Droga: Western medicine
Western medicine（Femoston 2/10)
Droga: traditional Chinese medicine
traditional Chinese medicine(Ba Zhen Yi Mu Pill and Dingkun Dan）

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Menstrual patterns during treatment and after discontinuation
Periodo de tiempo: From enrollment, during the treatment of 6 months, and within 3 months after treatment
Document the number of episodes of menstruation during the treatment and follow-up period
From enrollment, during the treatment of 6 months, and within 3 months after treatment
Sex hormone levels
Periodo de tiempo: from enrollment to the end of treatment at 6 months
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).
from enrollment to the end of treatment at 6 months
Uterine volume
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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.
From enrollment to the end of treatment at 6 months
Quality of Life Score(36-Item Short Form Health Survey，SF 36)
Periodo de tiempo: From enrollment to the end of treatment at 6 months
The SF-36 (36-Item Short Form Health Survey) score ranges from 0 to 100, where higher scores represent better quality of life outcomes.
From enrollment to the end of treatment at 6 months
Total ovarian volume
Periodo de tiempo: from enrollment to the end of treatment at 6 months
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.
from enrollment to the end of treatment at 6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Depressive symptoms were assessed using the Beck Depression Inventory-II (BDI-II)
Periodo de tiempo: From enrollment to 3 months after the end of treatment
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).
From enrollment to 3 months after the end of treatment
Anxiety symptoms were assessed using the Generalized Anxiety Disorder 7-item (GAD-7) scale.
Periodo de tiempo: From enrollment to 3 months after the end of treatment
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).
From enrollment to 3 months after the end of treatment
Perceived stress was assessed using the 10-item Perceived Stress Scale (PSS-10)
Periodo de tiempo: From enrollment to 3 months after the end of treatment
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).
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)
Periodo de tiempo: 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) . 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
From enrollment to 3 months after the end of treatment

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Periodo de tiempo: From enrollment to the end of treatment at 6 months
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
From enrollment to the end of treatment at 6 months
Serum alanine aminotransferase (ALT) levels were measured to assess liver function.
Periodo de tiempo: From enrollment to 3 months after the end of treatment.
Serum alanine aminotransferase (ALT) levels were measured to assess liver function. Elevated ALT levels indicate hepatocellular injury (worse outcome).
From enrollment to 3 months after the end of treatment.
Renal function was assessed by measuring serum creatinine (SCr) levels
Periodo de tiempo: From enrollment to 3 months after the end of treatment
Renal function was assessed by measuring serum creatinine (SCr) levels. Serum creatinine levels were measured, with higher levels indicating worse renal function (worse outcome) .
From enrollment to 3 months after the end of treatment
Physical activity was assessed using the short form of the International Physical Activity Questionnaire (IPAQ-SF) .
Periodo de tiempo: From enrollment to 3 months after the end of treatment
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) .
From enrollment to 3 months after the end of treatment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Peking Union Medical College Hospital

Colaboradores

Guangdong Provincial Hospital of Traditional Chinese Medicine
Peking University Third Hospital
Beijing University of Chinese Medicine
Dongfang Hospital Beijing University of Chinese Medicine
Beijing University of Chinese Medicine Third Affiliated Hospital
Shenyang Women's and Children's Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

22 de octubre de 2025

Finalización primaria (Estimado)

30 de junio de 2028

Finalización del estudio (Estimado)

30 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

27 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

5 de mayo de 2026

Publicado por primera vez (Actual)

12 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

12 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de mayo de 2026

Última verificación

1 de octubre de 2025

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 2025YFC3508004 (Otro número de subvención/financiamiento: National Key Research and Development Program of China)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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