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| Name | Class |
|---|---|
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | OTHER |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Tianjin Medical University | OTHER |
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In order to reduce the clinical demand for kidney dialysis rate of Diabetic Kidney Disease（DKD） patients, a bidirectional cohort study of 4472 patients with DKD (Qi deficiency and collateral stasis syndrome) was carried out based on a preliminary DKD cohort of 13,000 patients. The exposure factor was supplementing and reducing the kidney turbidity-Huoxue Tongluo method represented by the addition and subversion of Shenzhuo prescription, and the incidence of end-stage renal disease was the main therapeutic index. Follow-up was conducted for 2 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | People receiving exposure factors:In addition to the basic treatment and non-Yiqi Jiangzhuo Huoxue Tongluo Chinese patent medicine(except for Niaoduqing Granules, Shenshuaining Tablets/Capsules,Qizhi Capsules,Qizhi Yishen Capsules and other Chinese patent medicine),the exposure factors were treated with Shenqi Decoction(composed of Astragalus,Salvia miltiorrhiza,Leech,Rhubarb,Epimedium,Motherwort)as the representative of Yiqi Jiangzhuo Huoxue Tongluo Chinese medicine prescription treatment,and did not receive other traditional Chinese medicine treatment measures for urinary protein or renal insufficiency.The definition of basic treatment is:standardized diet,exercise,hypoglycemic,antihypertensive,lipid-lowering and other basic treatment measures,appropriate doses of angiotensin converting enzyme inhibitors(ACEI)/angiotensin receptor blockers(ARB),sodium-glucose co-transporter 2 inhibitors(SGLT2i),salt hormone receptor antagonists(MRA) and other drugs with clear renal protective effect | ||
| Non-exposed group | Diabetic kidney disease patients who did not receive exposure factors. |
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of end-stage renal disease | dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of renal composite outcome indicators | End-stage renal disease [ dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 ) ], eGFR decreased by more than 50 %, renal causes of death were defined. | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | Body temperature | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| blood pressure | Both systolic and diastolic blood pressures should be measured. |
Inclusion Criteria:
Exclusion Criteria:
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Diabetic kidney disease patients, in line with the inclusion criteria, do not meet the exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingqing Liu | Contact | +8615811362511 | 125982343@qq.com | |
| Fengyi Cai | Contact | +8618810623691 | cfy201802@163.com |
| Name | Affiliation | Role |
|---|---|---|
| HongFang Liu | Dongzhimen Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital of BeijingUniversity of Chinese Medicine | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Changchun University of Chinese Medicine |
| OTHER |
| EFONG PHARMRCEUTICRL | UNKNOWN |
| Xinxiang Central Hospital of Henan province | UNKNOWN |
| Xiamen Hospital of Traditional Chinese Medicine | OTHER |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
| Beijing Tiantan Hospital | OTHER |
| Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine | OTHER |
| Hubei Zhongshan Hospital Affiliated to Wuhan University | UNKNOWN |
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| Changes of urinary protein creatinine ratio | Changes of urinary protein creatinine ratio | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Changes of 24-hour urinary protein level | Changes of 24-hour urinary protein level | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Estimate the change value of glomerular filtration rate ( eGFR ) level, slope | Estimate the change value of glomerular filtration rate ( eGFR ) level, slope | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Chinese medicine syndrome scores | The TCM（Traditional Chinese Medicine） symptoms of the patients were scored by the TCM syndrome scale in order to judge the improvement of their symptoms.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health. | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| respiration | respiration | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years. |
| heart rate | heart rate | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal white blood cell count ( WBC ) | Number of participants with abnormal white blood cell count ( WBC ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal electrocardiogram | Number of participants with abnormal electrocardiogram | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years |
| glycosylated hemoglobin | glycosylated hemoglobin | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years |
| fasting blood glucose | fasting blood glucose | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years |
| incidence of adverse events | incidence of adverse events | Review period, enrollment, enrollment after two months, enrollment after half a year, enrollment after 1 year, enrollment after 1 and a half years, enrollment after two years |
| Number of participants with abnormal red blood cell count ( RBC ) | Number of participants with abnormal red blood cell count ( RBC ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal hemoglobin ( HGB ) | Number of participants with abnormal hemoglobin ( HGB ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal lymphocyte percentage ( LY % ) | Number of participants with abnormal lymphocyte percentage ( LY % ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Percentage of neutrophils( NE % ) | Number of participants with abnormal Percentage of neutrophils( NE % ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Platelet count ( PLT ) | Number of participants with abnormal Platelet count ( PLT ) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urine PH value | Number of participants with abnormal Urine PH value | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urinary protein | Number of participants with abnormal Urinary protein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urine occult blood | Number of participants with abnormal Urine occult blood | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urinary glucose | Number of participants with abnormal Urinary glucose | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urine ketone | Number of participants with abnormal Urine ketone | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urine white blood cells (high magnification field of view) | Number of participants with abnormal Urine white blood cells (high magnification field of view) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Urine red blood cells (high magnification field of view) | Number of participants with abnormal Urine red blood cells (high magnification field of view) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum alanine aminotransferase | Number of participants with abnormal Serum alanine aminotransferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum aspartate aminotransferase | Number of participants with abnormal Serum aspartate aminotransferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum alkaline phosphatase | Number of participants with abnormal Serum alkaline phosphatase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum gamma-glutamyl transferase | Number of participants with abnormal Serum gamma-glutamyl transferase | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum albumin (ALB) | Number of participants with abnormal Serum albumin (ALB) | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum total bilirubin（TBIL） | Number of participants with abnormal Serum total bilirubin（TBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum direct bilirubin（DBIL） | Number of participants with abnormal Serum direct bilirubin（DBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Number of participants with abnormal Serum indirect bilirubin（IBIL） | Number of participants with abnormal Serum indirect bilirubin（IBIL） | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Serum urea | Serum urea | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Serum urate | Serum urate | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Serum cystatin C | Serum cystatin C | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Serum creatinine | Serum creatinine | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Plasma triglyceride | Plasma triglyceride | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Plasma high-density lipoprotein | Plasma high-density lipoprotein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Plasma total cholesterol | Plasma total cholesterol | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Plasma low-density lipoprotein | Plasma low-density lipoprotein | Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years |
| Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel | Beijing | Beijing Municipality | China |
|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | China |
|
| The Affiliated Hospital to ChangChun University of Chinese Medicinecancel | Changchun | Jilin | China |
|
| Tianjin Medical University Chu Hsien-I Memorial Hospital | Tianjin | Tianjin Municipality | China |
|
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |