Clinical Study on the Effectiveness and Safety of Guanxinning Tablets on Coronary Heart Disease Complicated with Diabetic Nephropathy

Phase 4

• Conditions: Coronary heart disease combined with diabetic nephropathy

• Registration Number: ITMCTR2100005416
• Lead Sponsor: Affiliated Hospital of Hangzhou Normal University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
24-hour urine protein quantification;Urine albumin/creatinine ratio;Estimated glomerular filtration rate;

Secondary Outcome Measures

Name	Time	Method
Changes in inflammation levels;Glycated hemoglobin;Fasting blood glucose;Blood lipids;