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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
228
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.
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.
Dongzhimen Hospital
Beijing, Beijing Municipality, China
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
Glomerular filtration rate ( eGFR ) decline slope
Time frame: At the time of enrollment, 6 months ± 1 week, 12 months ± 1 week, 18 months ± 1 week, 24 months ± 1 week after enrollment.
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
Time frame: 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.
Urinary albumin creatinine ratio (UACR )
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
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