Effect and Mechanism of Jiajian Guishen Optimized Formula on Premature Ovarian Insufficiency: Insights Into m6A Modification and Oxidative Stress (JJGS ; POI)
The goal of this clinical study is to evaluate the effectiveness of JiaJian GuiShen Optimized Formula (JJGS) and explore its mechanisms involving m6A modification and oxidative stress in women with premature ovarian insufficiency (POI). The main question it aims to answer is:
Does JJGS improve ovarian function in women with POI after three menstrual cycles of treatment? Twenty-five women with POI will receive JJGS, and 20 healthy women will serve as controls. Changes in FSH, E2, LH, AMH, oxidative stress markers, plasma FTO levels, whole-blood RNA m6A levels, and symptom scores will be analyzed before and after treatment.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yun Shi
- Número de teléfono: +8613717926522
- Correo electrónico: zhyshiyun@126.com
Copia de seguridad de contactos de estudio
- Nombre: Xiyu Li
- Número de teléfono: +8619212951890
- Correo electrónico: 18165120161@163.com
Ubicaciones de estudio
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Beijing, Porcelana
- Dongzhimen Hospital, Beijing University of Chinese Medicine
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Contacto:
- Xueting Han
- Número de teléfono: +861084012709
- Correo electrónico: dzmyyec@126.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
Inclusion Criteria for Participants with POI: 1. Meeting the Western medicine diagnostic criteria for premature ovarian insufficiency (POI); 2. Meeting the traditional Chinese medicine diagnostic criteria for the kidney deficiency and liver stagnation syndrome; 3. Aged 18-39 years; 4. Willing and able to provide written informed consent. Participants must meet all four criteria to be included.
Inclusion Criteria for Healthy Participants: 1. Aged 18-39 years; 2. Regular menstrual cycles; 3. Normal sex hormone and anti-Müllerian hormone (AMH) levels; 4. Willing to participate in the study and provide written informed consent.
Exclusion Criteria:
Exclusion Criteria for Participants with POI: 1. Congenital gonadal dysgenesis or a family history of premature menopause; 2. POI caused by acquired organic disease or ovarian surgery; 3. Treatment with artificial menstrual cycle therapy or other hormonal therapy within the previous three months; 4. Severe cardiovascular, cerebrovascular, hepatic, renal, hematopoietic, or psychiatric disorders; 5. Known allergy to any component of the study medication. Participants meeting any of the above criteria will be excluded.
Exclusion Criteria for Healthy Participants: The same as criteria 1, 3, 4, and 5 above.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: JJGS treatment group
JJGS is a traditional Chinese medicine formula administered to patients with POI for three menstrual cycles. Blood samples will be collected before and after treatment. |
JJGS is a traditional Chinese medicine formulation. Patients with POI will receive the formula for three menstrual cycles, and blood samples will be collected before and after treatment. Participants in the healthy control group will receive no intervention, and their blood samples will be collected at enrollment. |
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Sin intervención: Healthy control group
healthy people |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Follicle-Stimulating Hormone (FSH)
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum Anti-Müllerian Hormone (AMH) Level
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Serum Luteinizing Hormone (LH)
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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FSH/LH Ratio
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Change in FSH/LH ratio before and after treatment. |
From baseline to 3 months after treatment initiation
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Serum Estradiol (E2)
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Traditional Chinese Medicine Syndrome Score
Periodo de tiempo: before and 1 month after the treatment
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This syndrome score evaluates three primary symptoms and twelve secondary symptoms related to traditional Chinese medicine syndrome differentiation. Total scores range from 0 to 48, with higher scores indicating more severe syndrome manifestations and a worse clinical outcome. |
before and 1 month after the treatment
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Modified Kupperman Menopausal Index (KMI)
Periodo de tiempo: before and 1 month after the treatment
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The modified KMI consists of 13 menopausal symptoms, each rated on a 0-3 severity scale and weighted by symptom-specific coefficients. Total scores range from 0 to 63, with higher scores indicating more severe menopausal symptoms and a worse clinical outcome. |
before and 1 month after the treatment
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Incidence of Treatment-Emergent Adverse Events
Periodo de tiempo: From baseline to 3 months after treatment initiation
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The incidence of treatment-emergent adverse events during the treatment period will be assessed, including gastrointestinal symptoms and abnormalities in liver and renal function. |
From baseline to 3 months after treatment initiation
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HO-1
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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NQO1
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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CAT
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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SOD
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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MDA
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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FTO
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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m6a
Periodo de tiempo: From baseline to 3 months after treatment initiation
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Blood samples are collected before and after treatment. |
From baseline to 3 months after treatment initiation
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pregnancy Rate
Periodo de tiempo: From baseline to 3 months after treatment initiation
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The proportion of participants with fertility needs who achieved pregnancy during the 3-month treatment period will be recorded as an exploratory outcome. |
From baseline to 3 months after treatment initiation
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades Genitales Femeninas
- Enfermedades Ováricas
- Enfermedades anexiales
- Trastornos gonadales
- Insuficiencia ovárica primaria
Otros números de identificación del estudio
- 2025DZMEC-450-03
- 2025DZMEC-450-03 (Otro identificador: Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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