NCT Number: NCT07032116
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
Trial opening soon.
Get Notified18 year–80 year
All sexes
Observational
Dongzhimen Hospital of BeijingUniversity of Chinese Medicine, Beijing, Beijing Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
dialysis, transplantation or glomerular filtration rate ( eGFR ) < 15ml / ( min · 1.73m2 )
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
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.
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Changes of urinary protein creatinine ratio
Time frame: 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
Time frame: 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
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
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.
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Body temperature
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Both systolic and diastolic blood pressures should be measured.
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years.
respiration
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
heart rate
Time frame: 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 )
Time frame: 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 electrocardiogram
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 red blood cell count ( RBC )
Time frame: 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 )
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Number of participants with abnormal lymphocyte percentage ( LY % )
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Number of participants with abnormal Percentage of neutrophils( NE % )
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Number of participants with abnormal Platelet count ( PLT )
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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）
Time frame: 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）
Time frame: 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）
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Serum urea
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Serum urate
Time frame: 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
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Serum creatinine
Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years
Plasma triglyceride
Time frame: 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
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Fengyi Cai
CONTACT
Qingqing Liu
CONTACT
Liu Hongfang
Other
Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 1
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