Chronic Kidney Disease
Conditions
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.
Interventions
DRUGShenyan Kangfu Tablet
Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
Sponsors
Tianjin TongRenTang Group Co., Ltd.
Chen Xiangmei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosed with primary glomerulonephritis or diabetic nephropathy; 2. Aged from 18 to 70 years，male or female 3. GFR≥45ml/min/1.73㎡ 4. 0.5g≤24 hours proteinuria≤3.0g 5. glycated hemoglobin (HbAlc) ≤8% (This has been limited to patients with diabetic nephropathy) 6. Traditional Chinese medicine syndrome conform Qi-Yin Deficiency 7. Obtain the agreement of patients or their guardians, and signed informed consent file
Exclusion criteria
1. Secondary nephropathy 2. People allergic to Shenyankangfu tables 3. Combined with severe primary disease of heart, brain, liver and hematopoietic system, or other serious diseases can affect patient's life 4. Pregnant or lactating women 5. Be participating in another clinical study at the same period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour urinary protein excretion | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Glomerular filtration rate | 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Potassium detection | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Routine blood test | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Adverse events / adverse reactions | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times | Follow-up 3 times.Subject at any time to contact your doctor. |
| blood glucose testing | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Routine urine test | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Liver function | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
| Electrocardiograph | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times | — |
| chest radiography | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times | — |
| Renal function tests | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times | — |
Countries
China
Contacts
Primary ContactJie Wu, chaieman
Backup ContactSiJi Li, director
Outcome results
None listed