(Diabetic Nephropathy). Type 2 diabetes mellitus with diabetic nephropathy
Conditions
Interventions
Intervention 1: Intervention Group: Intervention Name: Tablet containing standardized extract of Milk ThistleMain Active Chemical Composition: Silymarin, a flavonolignan complex comprising several com
Sponsors
Islamic Azad University
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with Type 2 Diabetes Mellitus. Age of participants between 35 and 75 years Individuals must declare their informed consent to participate in the study and sign the consent form. Patients with pre-existing proteinuria or albuminuria accompanied by reduced GFR.
Exclusion criteria
Exclusion criteria: Patients with advanced CKD (Chronic Kidney Disease). Patients with eGFR less than or equal to 30 ml/min/1.73 m² Patients with Type 1 Diabetes. Patients with a history of kidney transplantation. Patients who are pregnant or breastfeeding. Patients with a history of addiction to narcotics or alcohol, or active cigarette smoking. Patients with active malignant diseases at the start of the study. Patients with a history of hypersensitivity or adverse reaction to Silymarin or similar compounds Patients with CKD or a cause of kidney disease other than diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. UACR (Urine Albumin-to-Creatinine Ratio). Timepoint: 1. Baseline MeasurementTiming: Before the start of the interventionSampling Conditions:Blood: After a 12-hour fastUrine: Random urine sample or 24-hour collection2. Final Measurement (Endpoint)Timing: After 3 months (90 days)Sampling Conditions:Blood: After a 12-hour fastUrine: Random urine sample or 24-hour. Method of measurement: Urine Albumin-to-Creatinine Ratio;Measurement Method: A random urine sample is collected from the patient. The concentrations of albumin and creatinine in the urine sample are measured using immunoassay and colorimetric methods in the laboratory. The albumin value is then divided by the creatinine value to calculate the result. Proteinuria Measurement Method: A random urine sample is collected from the patient. The amount of protein in the urine is measured using the pyrogallol red colorimetric method in the laboratory. Glomerular Filtration RateMeasurement Method: A venous blood sample is drawn from the patient in a fasting state. The serum creatinine level is measured by a colorimetric method. The Glomerular Filtration Rate is then calculated using the Chronic Kidney Disease Epidemiology Collaboration formula, which considers the patient's age, sex, and race. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactTerifeh Ahmadi
Islamic Azad University
Outcome results
None listed