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Niaoduqing Granules in Older Adults With Impaired Kidney Function

28 de julio de 2026 actualizado por: Chen Jing, Huashan Hospital

A Study of the Clinical Benefits of Niaoduqing Granules in Older Adults With Impaired Renal Function

This prospective real-world study will evaluate the clinical benefits of Niaoduqing Granules in older adults with impaired kidney function. Approximately 300 participants aged over 60 years with stage 3 to 5 chronic kidney disease who are not receiving dialysis will be enrolled at Huashan Hospital, Fudan University. The study will examine whether treatment with Niaoduqing Granules is associated with slower kidney function decline and improvements in nutrition, frailty, and other health outcomes.

Participants will receive 5 g of Niaoduqing Granules three times daily after meals for 12 months, while continuing their usual treatment for chronic diseases as directed by their physicians. Kidney function, laboratory results, nutritional status, frailty, cardiovascular and cerebrovascular events, and survival will be assessed during follow-up. Blood, urine, and stool samples will also be collected to study changes in gut microorganisms and blood metabolites that may help explain how Niaoduqing Granules affect health. Participants will be followed for up to 60 months.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

300

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: Jing Chen, Professor and Chief Physician
  • Número de teléfono: +86 021-52889000
  • Correo electrónico: chenjing1998@fudan.edu.cn

Ubicaciones de estudio

  • Porcelana
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 20040
        • Reclutamiento
        • Huashan Hospital, Fudan University
        • Contacto:

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

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Participants with stage 3 to 5 chronic kidney disease who are not receiving dialysis.
  2. Age older than 60 years.
  3. The participant or a family member has sufficient literacy and is able to comply with dietary diary recording and other study-related examinations.
  4. The underlying cause of chronic kidney disease is clinically stable.

Exclusion Criteria:

  1. Malignancy, severe cardiovascular disease, osteoporosis, or severe hematopoietic system disease.
  2. Active infection, defined as C-reactive protein greater than 10 mg/L, or current use of nephrotoxic medications.
  3. Limb paralysis or major limb impairment.
  4. Use of immunosuppressive therapy, including cyclosporine or tacrolimus, within the 3 months before cohort enrollment, or use of corticosteroids at a dose equivalent to more than 10 mg/day of prednisone.
  5. Severe gastrointestinal disease affecting nutrient absorption.
  6. Current participation in, or participation within the previous month in, another study related to diet or medication.
  7. Known allergy to Niaoduqing Granules.
  8. Any condition that, in the investigator's judgment, makes the participant unsuitable for the study.

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Niaoduqing Granules
Participants will receive Niaoduqing Granules 5 g orally three times daily at 6:00, 12:00, and 18:00 after meals for 12 months. Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions will be continued or adjusted according to specialist recommendations.
Droga: Intervention Name
Niaoduqing Granules will be administered orally at a dose of 5 g three times daily at 6:00, 12:00, and 18:00 after meals with warm water for 12 months. Usual treatments for chronic kidney disease, age-related comorbidities, and other chronic conditions may be continued or adjusted according to specialist recommendations.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Occurrence of Rapid Kidney Function Decline
Periodo de tiempo: Every 12 months from baseline through Month 60
Rapid kidney function decline is defined as an annual decrease in estimated glomerular filtration rate (eGFR) of more than 5%. The occurrence of rapid kidney function decline will be determined using serial kidney function measurements obtained during follow-up.
Every 12 months from baseline through Month 60

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of Chronic Kidney Disease Complications
Periodo de tiempo: Every 12 months from baseline through Month 60
The number and percentage of participants who develop chronic kidney disease complications, including renal anemia and/or chronic kidney disease-mineral and bone disorder (CKD-MBD), during follow-up. Outcomes will be assessed using clinical evaluations and relevant laboratory test results collected according to the study protocol.
Every 12 months from baseline through Month 60
Occurrence of Malnutrition
Periodo de tiempo: At baseline and every 12 months through Month 60
Malnutrition will be assessed using the Global Leadership Initiative on Malnutrition (GLIM) criteria. A participant will be classified as having malnutrition when at least one phenotypic criterion, including involuntary weight loss, low body mass index, or reduced muscle mass, and at least one etiologic criterion, including reduced food intake or absorption or disease burden/inflammation, are present.
At baseline and every 12 months through Month 60
Occurrence of Frailty
Periodo de tiempo: At baseline and every 12 months through Month 60
Frailty status will be assessed using a rapid geriatric frailty screening scale. The number and percentage of participants identified as having frailty according to the screening assessment will be recorded.
At baseline and every 12 months through Month 60
Occurrence of Cardiovascular and Cerebrovascular Events
Periodo de tiempo: From baseline through Month 60
The number and percentage of participants who experience one or more cardiovascular or cerebrovascular events during follow-up. Events include acute myocardial infarction, unstable angina, coronary heart disease, acute heart failure or worsening chronic heart failure, new-onset arrhythmia, acute cerebral infarction, transient ischemic attack, intracerebral hemorrhage, peripheral vascular disease, rheumatic heart disease, deep vein thrombosis, pulmonary embolism, valvular heart disease, or aortic disease.
From baseline through Month 60
All-Cause Mortality
Periodo de tiempo: From baseline through Month 60
The number and percentage of participants who die from any cause during the study follow-up period.
From baseline through Month 60

Colaboradores e Investigadores

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

Patrocinador

Huashan 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)

1 de diciembre de 2025

Finalización primaria (Estimado)

30 de noviembre de 2030

Finalización del estudio (Estimado)

30 de noviembre de 2030

Fechas de registro del estudio

Enviado por primera vez

28 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de julio de 2026

Publicado por primera vez (Actual)

3 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

3 de agosto de 2026

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

28 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • KY2024-1366

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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