Diabetic Kidney Disease (DKD)
Conditions
Brief summary
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.
Interventions
DRUGthe traditional Chinese medicine prescription ' Shenzhuo Decoction '
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.
COMBINATION_PRODUCTbasic treatment
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.
Sponsors
Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel
First Affiliated Hospital, Sun Yat-Sen University
Tianjin Medical University Chu Hsien-I Memorial Hospital
The Affiliated Hospital to ChangChun University of Chinese Medicinecancel
EFONG PHARMRCEUTICRL
Liu Hongfang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
the practical randomized controlled trial designed by Zelen
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 1 In line with the diagnostic criteria of Western medicine type 2 DKD ; * 2 18-80 years old, regardless of gender ; * 3 30ml / min / 1.73m2 ≤ eGFR \< 60ml / min / 1.73m2 ( eGFR was calculated according to CKD-EPI formula ) ; * 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ; * 5 hbA1c between 7-10 % ; * 6 uACR ≥ 300mg / g * 7 blood pressure ≤ 150 / 90mmHg ; * 8 signed the informed consent ;
Exclusion criteria
* 1 Patients who are currently receiving other traditional Chinese medicines and Chinese patent medicines with DKD therapeutic effects ; * 2 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumors ; * 3 Patients with acute or chronic infection who needed treatment were judged by the researchers not suitable for inclusion in the study ; * 4 Patients who participated in any other research drug study and / or received or had received another research drug or intervention treatment ( within one month before signing the informed consent form ) ; * 5 patients who were allergic or contraindicated to the planned use of drugs ; * 6 There are serious acute or chronic diseases that the major researchers believe may pose an excessive risk to the subjects, including : patients with cardiovascular, cerebrovascular, lung, blood, digestive tract, liver, kidney, neuropsychiatric or infectious diseases ; * 7 Patients with a history of immunodeficiency, including patients with other acquired, congenital immunodeficiency diseases, or patients with a history of organ transplantation or planned organ transplantation ; * 8 Women with positive pregnancy screening test or lactating or planning to get pregnant in the next 24 months. Female or male patients who were reluctant to use contraception throughout the study period ; * 9 patients with a history of malignant tumors within 5 years ; * 10 patients with type 1 diabetes ; * 11 patients with maintenance dialysis \> 2 weeks and / or expected maintenance dialysis \> 8 weeks before treatment and patients who were judged by any researcher not suitable for inclusion in the trial.
Design outcomes
Primary
| Measure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of renal composite outcome | 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. | 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 |
| 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 | 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 electrocardiogram |
| 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 hemoglobin ( HGB ) |
| 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. | Number of participants with abnormal lymphocyte percentage ( LY % ) |
| 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 % ) | 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 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 Platelet count ( PLT ) |
| 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 Urine PH value |
| 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 Urinary protein |
| 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 Urine occult blood |
| 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 Urinary glucose |
| 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 ketone |
| 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 white 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 Urine red blood cells (high magnification field of view) |
| 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 alanine 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 aspartate aminotransferase |
| 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 alkaline phosphatase |
| 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 gamma-glutamyl transferase |
| 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 albumin (ALB) |
| 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. | — |
| 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 direct bilirubin（DBIL） |
| 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. | Number of participants with abnormal Serum indirect bilirubin （IBIL） |
| 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 urea |
| 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 urate |
| 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 cystatin C |
| 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. | Serum creatinine |
| 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 triglyceride |
| 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 high-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 low-density lipoprotein |
| 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. | Plasma total cholesterol |
| 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 total bilirubin（TBIL） |
| blood pressure | 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. | Both systolic and diastolic blood pressures should be measured |
| 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 ) | 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 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 red blood cell count ( RBC ) |
Countries
China
Contacts
Primary ContactQingqing Liu
Backup ContactFengyi Cai
Outcome results
None listed