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Not yet recruiting NCT07032116

YiqiJiangzhuoHuoxueTongluo Method to Delay the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study1

— Observational Diabetic Kidney Disease (DKD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Diabetic Kidney Disease (DKD). Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evidence-based Evaluation of Yiqi Jiangzhuo Huoxue Tongluo Method in Delaying the Occurrence of End-stage Renal Disease in Diabetic Kidney Disease--Study 1

Overview

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

Primary outcome measures

  • The incidence of end-stage renal disease [Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]
Secondary outcome measures (5)
  • Incidence of renal composite outcome indicators [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]
  • Chinese medicine syndrome scores [Time frame: Review period, enrollment, enrollment two months, enrollment half a year, enrollment 1 year, enrollment 1 and a half years, enrollment two years]

Eligibility criteria

Inclusion criteria

  • 1 in line with Western medicine diagnostic criteria for type 2 diabetic kidney disease ;
  • 2 18-80 years old, regardless of gender ;
  • 3 eGFR > 15ml / ( min · 1.73m2 ) ; the eGFR was calculated according to the chronic kidney disease epidemiology collaboration equation ( CKD-EPI ).
  • 4 In line with the diagnostic criteria of qi deficiency and collateral stasis syndrome in traditional Chinese medicine ;
  • 5glycosylated hemoglobin ( HbA1c ) between 7-10 % ;
  • 6 blood pressure ≤ 160 / 100mmHg ;
  • 7 to sign the informed consent ;

Exclusion criteria

  • 1 combined with other clear renal diseases, such as polycystic kidney disease, glomerulonephritis, renal tumor, etc. ;
  • 2 patients with a history of recurrent genitourinary tract infection ;
  • 3 combined with cardiovascular and cerebrovascular, digestive, respiratory, urinary, immune system serious diseases or mental diseases ;
  • 4 currently in pregnancy, lactation, or pregnancy plan women ;
  • 5 Patients with type 1 diabetes.
  • 6 Tumor patients undergoing radiotherapy, chemotherapy or targeted therapy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 5 centers
  • Dongzhimen Hospital of BeijingUniversity of Chinese Medicine — Beijing
  • Guang'anmen Hospital，China Academy of Chinese Medical Sciencescancel — Beijing
  • The First Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • The Affiliated Hospital to ChangChun University of Chinese Medicinecancel — Changchun
  • Tianjin Medical University Chu Hsien-I Memorial Hospital — Tianjin

Identifiers

NCT: NCT07032116 · 2023ZD0509303-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗