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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005416
Enrollment
Unknown
Registered
2021-12-17
Start date
2021-12-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary heart disease combined with diabetic nephropathy

Interventions

test group:Conventional treatment + Guanxinning tablets

Sponsors

Affiliated Hospital of Hangzhou Normal University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
24-hour urine protein quantification;Urine albumin/creatinine ratio;Estimated glomerular filtration rate;

Secondary

MeasureTime frame
Changes in inflammation levels;Glycated hemoglobin;Fasting blood glucose;Blood lipids;

Countries

china

Contacts

Public ContactXu Zhao
13735527510@163.com13735527510

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026