| Trial ID: | L6902 |
| Source ID: | NCT06425705
|
| Associated Drug: |
Silymarin
|
| Title: |
Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Silymarin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in the urinary albumin-creatinine ratio (UACR) from baseline, It was measured quantitatively by comparing the urinary albumin-creatinine ratio (UACR) in mg/g between initial recruitment and subsequent follow-up visits at one and three months., Outcomes monitored at one and three-month intervals|Change in estimated glomerular filtration rate (eGFR) from baseline, eGFR was calculated using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula, which incorporates serum creatinine, age, sex, and race. The outcome measure was the change in eGFR in mL/min/1.73 m² at one month and three months compared to the baseline value., Outcomes monitored at one and three-month intervals|Change in HbA1c levels from baseline, It was measured quantitatively by comparing the HbA1c levels in percentage (%) between initial recruitment and subsequent follow-up visit after three months., Outcomes monitored after three-month. |
|
| Sponsor/Collaborators: |
Sponsor: Lahore General Hospital
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
70
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-02-25
|
| Completion Date: |
2023-07-10
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| Results First Posted: |
|
| Last Update Posted: |
2024-05-22
|
| Locations: |
Lahore General Hospital, Lahore, Lahore, Punjab, 54000, Pakistan
|
| URL: |
https://clinicaltrials.gov/show/NCT06425705
|
