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| Name | Class |
|---|---|
| Tianjin TongRenTang Group Co., Ltd. | UNKNOWN |
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Safety and efficacy of long-term application of Shenyankangfu Tablets in Large sample of patients with chronic kidney disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenyan kangfu Tablets | Experimental | Shenyan Kangfu Tabletsï¼›Each weighing 0.48gï¼›Oralï¼›Once five, three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shenyan Kangfu Tablet | Drug | Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour urinary protein excretion | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Routine blood test | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wu, chaieman | Contact | 18210128683 | wujie301@126.com | |
| SiJi Li, director | Contact | 13821669488 | miaoshujie@yeah.net |
| Name | Affiliation | Role |
|---|---|---|
| YongLi Zhan, investigator | Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Principal Investigator |
| HongTao Yang, investigator | First Teaching Hospital of Tianjin University of Traditional Chinese Medicine |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Clinical Research Center for Kidney Disease, State Key Laboratory of Kidney Disease, Department of Nephrology, Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C583767 | shenyan kangfu |
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| Albumin | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |
| Glycated hemoglobin | Observations of the project value and the percentage change in value before and after the treatment. | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times |
| Symptom scores | 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 |
| Renal function tests | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |
| Potassium detection | Observation time: 24 weeks.Tested once every 12 weeks, it was detected three times |
| blood glucose testing | 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 |
| Adverse events / adverse reactions | Follow-up 3 times.Subject at any time to contact your doctor. | Observation time: 24 weeks.Tested once every 24 weeks, were detected in 2 times |
| Meng Liang, investigator | 174th hospital of the People's Liberation Army | Principal Investigator |
| Lu Ma, investigator | Beidaihe Sanatorium of Beijing Military Mrca | Principal Investigator |
| LiQun Song, investigator | Heilongjiang University of Chinese Medicine | Principal Investigator |
| QiaoLing Zhou, investigator | Xiangya Hospital of Central South University | Principal Investigator |
| Ping Luo, investigator | Second Hospital of Jilin University | Principal Investigator |
| RongShan Li, investigator | Shanxi provincial peple's hospital | Principal Investigator |
| XiaoHong Cheng, investigator | Shaanxi Traditional Chinese Medicine Hospital | Principal Investigator |
| Jie Wu, investigator | Chinese PLA General Hospital | Principal Investigator |
|
| Guang'anmen Hospital, China Academy of Chinese Medical Sciences | Recruiting | Beijing | Beijing Municipality | China |
| Daping Hospital,Research Institute of Surgery Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| Fuzhou General Hospital Nanjing Military Command | Recruiting | Fuzhou | Fujian | China |
| 174th hospital of the People's Liberation Army | Recruiting | Xiamen | Fujian | China |
| Beidaihe Sanatorium of Beijing Military Mrca | Recruiting | Qinhuangdao | Hebei | China |
| Heilongjiang University of Chinese Medicine | Recruiting | Harbin | Heilongjiang | China |
| Henan Provincial People'S Hospital | Recruiting | Zhengzhou | Henan | China |
| Shandong Province Hospital | Recruiting | Jinan | Shandong | China |
| Changhai Hospital of Shanghai | Recruiting | Shanghai | Shanghai Municipality | China |
| LONGHUA Hospital Shanghai University of TCM | Recruiting | Shanghai | Shanghai Municipality | China |
| First Hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | China |
| First Teaching Hospital of Tianjin University of TCM | Recruiting | Tianjin | Tianjin Municipality | China |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |