Safety and Efficacy of Shenyankangfu Tablets for Chronic Kidney Disease
- Conditions
- Chronic Kidney Disease
- Interventions
- Drug: Shenyan Kangfu Tablet
- Registration Number
- NCT02885857
- Lead Sponsor
- Chen Xiangmei
- Brief Summary
Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Shenyan kangfu Tablets Shenyan Kangfu Tablet Shenyan Kangfu Tablets；Each weighing 0.48g；Oral；Once five, three times a day
- Primary Outcome Measures
Name Time Method 24-hour urinary protein excretion Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
- Secondary Outcome Measures
Name Time Method Glomerular filtration rate Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times Serum creatinine Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times Albumin Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times Glycated hemoglobin Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times Observations of the project value and the percentage change in value before and after the treatment.
Symptom scores Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times
Trial Locations
- Locations (13)
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
🇨🇳Beijing, Beijing, China
National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China
Daping Hospital,Research Institute of Surgery Third Military Medical University
🇨🇳Chongqing, Chongqing, China
Beidaihe Sanatorium of Beijing Military Mrca
🇨🇳Qinhuangdao, Hebei, China
Shandong Province Hospital
🇨🇳Jinan, Shandong, China
Fuzhou General Hospital Nanjing Military Command
🇨🇳Fuzhou, Fujian, China
Heilongjiang University of Chinese Medicine
🇨🇳Harbin, Heilongjiang, China
First Teaching Hospital of Tianjin University of TCM
🇨🇳Tianjin, Tianjin, China
174th hospital of the People's Liberation Army
🇨🇳Xiamen, Fujian, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
Henan Provincial People'S Hospital
🇨🇳Zhengzhou, Henan, China
LONGHUA Hospital Shanghai University of TCM
🇨🇳Shanghai, Shanghai, China
First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China