Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
26 de agosto de 2016 actualizado por: Chen Xiangmei
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
Descripción general del estudio
Estado
Desconocido
Condiciones
Intervención / Tratamiento
Descripción detallada
Research purpose: Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
The crowd: patients with primary glomerular nephritis, diabetic nephropathy patients.
Study design: a multicenter clinical study design, openness. The study drug: Shenyan Kangfu Tablets. Statistical analysis: Research plan is determined, by statistical professionals responsible for negotiation with the principal investigator for statistical analysis plan.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
1500
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.
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana
- Reclutamiento
- Guang'anmen Hospital, China Academy of Chinese Medical Sciences
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Beijing, Beijing, Porcelana, 100853
- Reclutamiento
- National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
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Contacto:
- jie wu, doctor
- Correo electrónico: wujie301@163.com
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Investigador principal:
- xiangmei chen, doctor
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Chongqing
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Chongqing, Chongqing, Porcelana
- Reclutamiento
- Daping Hospital,Research Institute of Surgery Third Military Medical University
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Fujian
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Fuzhou, Fujian, Porcelana
- Reclutamiento
- Fuzhou General Hospital Nanjing Military Command
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Xiamen, Fujian, Porcelana
- Reclutamiento
- 174th hospital of the People's Liberation Army
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Hebei
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Qinhuangdao, Hebei, Porcelana
- Reclutamiento
- Beidaihe Sanatorium of Beijing Military Mrca
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Heilongjiang
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Harbin, Heilongjiang, Porcelana
- Reclutamiento
- Heilongjiang University of Chinese Medicine
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Henan
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Zhengzhou, Henan, Porcelana
- Reclutamiento
- Henan Provincial People's Hospital
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Shandong
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Jinan, Shandong, Porcelana
- Reclutamiento
- Shandong Province Hospital
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Shanghai
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Shanghai, Shanghai, Porcelana
- Reclutamiento
- Changhai Hospital of Shanghai
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Shanghai, Shanghai, Porcelana
- Reclutamiento
- LONGHUA Hospital Shanghai University of TCM
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Shanxi
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Taiyuan, Shanxi, Porcelana
- Reclutamiento
- First Hospital of Shanxi Medical University
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Tianjin
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Tianjin, Tianjin, Porcelana
- Reclutamiento
- First Teaching Hospital of Tianjin University of TCM
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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
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosed with primary glomerulonephritis or diabetic nephropathy;
- Aged from 18 to 70 years，male or female
- GFR≥45ml/min/1.73㎡
- 0.5g≤24 hours proteinuria≤3.0g
- glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy)
- Traditional Chinese medicine syndrome conform Qi-Yin Deficiency
- Obtain the agreement of patients or their guardians, and signed informed consent file
Exclusion Criteria:
- Secondary nephropathy
- People allergic to Shenyankangfu tables
- Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life
- Pregnant or lactating women
- Be participating in another clinical study at the same period
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 |
|---|---|
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Experimental: Shenyan kangfu Tablets
Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
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Observation period: 24 weeks.
The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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24-hour urinary protein excretion
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Serum creatinine
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Glomerular filtration rate
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Albumin
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Glycated hemoglobin
Periodo de tiempo: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Observations of the project value and the percentage change in value before and after the treatment.
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Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Symptom scores
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Routine blood test
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Routine urine test
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Liver function
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Renal function tests
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Potassium detection
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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blood glucose testing
Periodo de tiempo: Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
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Electrocardiograph
Periodo de tiempo: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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chest radiography
Periodo de tiempo: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Adverse events / adverse reactions
Periodo de tiempo: Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Follow-up 3 times.Subject at any time to contact your doctor.
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Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: YongLi Zhan, investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigador principal: HongTao Yang, investigator, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Investigador principal: Meng Liang, investigator, 174th hospital of the People's Liberation Army
- Investigador principal: Lu Ma, investigator, Beidaihe Sanatorium of Beijing Military Mrca
- Investigador principal: LiQun Song, investigator, Heilongjiang University of Chinese Medicine
- Investigador principal: QiaoLing Zhou, investigator, Xiangya Hospital of Central South University
- Investigador principal: Ping Luo, investigator, Second Hospital of Jilin University
- Investigador principal: RongShan Li, investigator, Shanxi provincial peple's hospital
- Investigador principal: XiaoHong Cheng, investigator, Shaanxi Traditional Chinese Medicine Hospital
- Investigador principal: Jie Wu, investigator, Chinese PLA General 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
1 de junio de 2015
Finalización primaria (Anticipado)
1 de diciembre de 2016
Finalización del estudio (Anticipado)
1 de diciembre de 2016
Fechas de registro del estudio
Enviado por primera vez
3 de junio de 2015
Primero enviado que cumplió con los criterios de control de calidad
26 de agosto de 2016
Publicado por primera vez (Estimar)
1 de septiembre de 2016
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
1 de septiembre de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
26 de agosto de 2016
Última verificación
1 de agosto de 2016
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- S2015-023-02
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. .