ITMCTR2100005416
Not yet recruiting
Phase 4
Clinical Study on the Effectiveness and Safety of Guanxinning Tablets on Coronary Heart Disease Complicated with Diabetic Nephropathy
Affiliated Hospital of Hangzhou Normal University0 sitesTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Affiliated Hospital of Hangzhou Normal University
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(1\) Meet the diagnostic criteria of blood stasis syndrome of coronary heart disease (Diagnostic criteria of blood stasis syndrome of coronary heart disease);
- •(2\) Meet the diagnostic criteria for diabetes (diabetes mellitus, DM) established by the ADA in 2020;
- •(3\) Those who meet one of the following conditions (Chinese Guidelines for Clinical Diagnosis and Treatment of Diabetic Kidney Disease 2021\):
- •?Random urinary albumin/creatinine ratio (UACR) \= \= CR or urinary albumin excretion rate (UAER) \= \= R white excretion rate (( sugar, and repeat check UACR or UACR within 3\-6 months) UAER, 2 out of 3 times reached or exceeded the critical value.
- •?Estimate the glomerular filtration rate (eGFR) \<60ml glomerular filtration rate (. Sugar 3m\-2, more than 3 months.
- •?Kidney biopsy conforms to the pathological changes of diabetic kidney disease (DKD).
- •(4\) Those aged \=18 years, \=, \=years old;
- •(5\) Subjects are informed and voluntarily sign an informed consent form.
Exclusion Criteria
- •(1\) Does not meet the inclusion criteria;
- •(2\) People with infection, fever, congestive heart failure, uncontrolled blood sugar and blood pressure, or urinary tract infection;
- •(3\) Unwilling to cooperate and mentally ill patients;
- •(4\) Patients with serious diseases such as heart, lung, brain, liver, kidney, hematopoietic system, etc.;
- •(5\) ALT and AST are higher than 3 times the upper limit of the normal range;
- •(6\) Patients who have participated in clinical trials of other drugs in the past month;
- •(7\) Women who are pregnant or preparing to become pregnant or breast\-feeding;
- •(8\) Those who have a history of drug allergy or allergic physique and are allergic to multiple drugs;
- •(9\) Other patients who do not meet the selection criteria as judged by the investigator.
Outcomes
Primary Outcomes
Not specified
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