Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel | UNKNOWN |
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Tianjin Medical University | OTHER |
Not provided
Not provided
Not provided
Using the practical randomized controlled trial designed by Zelen, the subjects were randomly divided into the experimental group and the control group. The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ), the control group was given basic treatment, a total of 1 year of drug intervention, followed up for 1 year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shenzhuo Decoction | Experimental | The experimental group was given the traditional Chinese medicine prescription ' Shenzhuo Decoction ' ( composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort ) + basic treatment ( including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc. ) |
|
| basic treatment | Active Comparator | the control group was given basic treatment, a total of 1 year of drug intervention（including nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, control of other risk factors, etc.） |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the traditional Chinese medicine prescription ' Shenzhuo Decoction ' | Drug | The traditional Chinese medicine prescription ' Shenzhuo Decoction ' is composed of Astragalus membranaceus, Salvia miltiorrhiza, Leech, Raw Rhubarb, Epimedium, Motherwort. It is a traditional Chinese medicine prescription for the treatment of diabetic kidney disease, which was founded by Tong Xiaolin, an academician of the Chinese Academy of Sciences. |
| Measure | Description | Time Frame |
|---|---|---|
| Glomerular filtration rate ( eGFR ) decline slope | At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of renal composite outcome | Defined as the occurrence of end-stage renal disease [ dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 ) ], eGFR decreased by more than 50 %, death caused by renal causes | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Measure | Description | Time Frame |
|---|---|---|
| Body temperature | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. | |
| blood pressure | Both systolic and diastolic blood pressures should be measured |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 | Beijing | Beijing Municipality | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Affiliated Hospital of Changchun University of Chinese Medicine |
| OTHER |
| EFONG PHARMRCEUTICRL | UNKNOWN |
the practical randomized controlled trial designed by Zelen
Not provided
Not provided
Not provided
Not provided
|
|
| basic treatment | Combination Product | Basic treatment includes six aspects : nutrition, lifestyle, hypoglycemic, hypotensive, lipid-lowering, and control of other risk factors, which are implemented in accordance with clinical standard treatment specifications. |
|
|
| Urinary albumin creatinine ratio (UACR ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Changes in 24-hour urinary protein levels | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Estimate the change value of glomerular filtration rate ( eGFR ) level, slope | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Changes of Traditional Chinese Medicine syndrome integrals | The symptoms of the patients were scored with the Traditional Chinese Medicine syndrome scale to better judge the changes of the symptoms of the patients.The highest score was 114 points, and the lowest score was 0 points. The higher the score, the worse the patient 's health. | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| respiration | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| heart rate | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal white blood cell count ( WBC ) | Number of participants with abnormal white blood cell count ( WBC ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal red blood cell count ( RBC ) | Number of participants with abnormal red blood cell count ( RBC ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal electrocardiogram | Number of participants with abnormal electrocardiogram | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal hemoglobin ( HGB ) | Number of participants with abnormal hemoglobin ( HGB ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal lymphocyte percentage ( LY % ) | Number of participants with abnormal lymphocyte percentage ( LY % ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| blood lipid | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| glycosylated hemoglobin | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| fasting blood glucose | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| incidence of adverse events | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Percentage of neutrophils( NE % ) | Number of participants with abnormal Percentage of neutrophils( NE % ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Platelet count ( PLT ) | Number of participants with abnormal Platelet count ( PLT ) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Urine PH value | Number of participants with abnormal Urine PH value | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Urinary protein | Number of participants with abnormal Urinary protein | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Urine occult blood | Number of participants with abnormal Urine occult blood | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Urinary glucose | Number of participants with abnormal Urinary glucose | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Urine ketone | Number of participants with abnormal Urine ketone | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| 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) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| 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) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum alanine aminotransferase | Number of participants with abnormal Serum alanine aminotransferase | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum aspartate aminotransferase | Number of participants with abnormal Serum aspartate aminotransferase | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum alkaline phosphatase | Number of participants with abnormal Serum alkaline phosphatase | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum gamma-glutamyl transferase | Number of participants with abnormal Serum gamma-glutamyl transferase | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum albumin (ALB) | Number of participants with abnormal Serum albumin (ALB) | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum total bilirubin（TBIL） | Number of participants with abnormal Serum total bilirubin（TBIL） | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum direct bilirubin（DBIL） | Number of participants with abnormal Serum direct bilirubin（DBIL） | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Number of participants with abnormal Serum indirect bilirubin （IBIL） | Number of participants with abnormal Serum indirect bilirubin （IBIL） | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Serum urea | Serum urea | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Serum urate | Serum urate | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Serum cystatin C | Serum cystatin C | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Serum creatinine | Serum creatinine | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Plasma triglyceride | Plasma triglyceride | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Plasma high-density lipoprotein | Plasma high-density lipoprotein | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Plasma low-density lipoprotein | Plasma low-density lipoprotein | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| Plasma total cholesterol | Plasma total cholesterol | Introduction period ( 1 month before enrollment ), enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment. |
| 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 |
|
| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
Not provided
Not provided