Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors (NCT06425705) | Clinical Trial Compass
CompletedPhase 2
Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors
Pakistan70 participantsStarted 2022-02-25
Plain-language summary
Given the inadequacies of existing pharmacological interventions for diabetic nephropathy, this study is predicated on the hypothesis that silymarin, having shown promise in mitigating hyperglycemia in diabetic patients without nephropathy and displaying renal protective effects in animal models, merits a thorough and systematic investigation. The current body of research on silymarin, particularly human trials, is limited by small cohorts and the preliminary nature of its outcomes. This research aims to evaluate the efficacy of silymarin as an adjunctive treatment in patients with Type 2 diabetes mellitus (T2DM) already on renin-angiotensin system inhibitors, focusing on its potential to reduce proteinuria and improve renal function. The ultimate objective is to amass more definitive evidence that could potentially inform a new therapeutic approach in the management of diabetic nephropathy.
Who can participate
Age range
35 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 35-70 years.
* Both male and female with Type II diabetes.
* Overt proteinuria defined by urinary albumin excretion \> 300 mg/24 hr. in 2 consecutive determinations despite treatment with highest FDA recommended doses of an angiotensin converting enzyme inhibitor or angiotensin receptor blocker for at least 6 months.
* Treatment of hyperglycemia with (but not limited to) an oral hypoglycemic agent or insulin (If a SGLT2 inhibitors is used, stable dose for at least 3 months).
* Treatment of hypercholesterolemia with (but not limited to) one medication from the class statins.
* Patients using stable dose of Non-Dihydropyridine Calcium Channel Blockers for at least 6 months as antihypertensive.
* Presence of diabetic retinopathy.
* Signing informed consent.
Exclusion Criteria:
* Type I diabetes.
* Advanced chronic kidney disease defined by estimated GFR \< 30 ml/min/1.73 m2
* Severely uncontrolled diabetes defined by HbA1C \> 10%.
* Uncontrolled hypertension defined by SBP \>140 mmHg or DBP \>90 mmHg despite antihypertensive therapy.
* Patients with organ transplant history.
* Secondary forms of hypertension with defined etiology other than diabetes mellitus.
* Other renal diseases.
* Chronic Heart Failure with NYHA class III or IV.
* Active infection.
* Pregnancy.
Use of one of the following medications within 2 months prior to enrollment in the study:
* Non-steroidal anti-inflammatory agents.
* Antioxidants supplements including vitamin…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the urinary albumin-creatinine ratio (UACR) from baseline
Timeframe: Outcomes monitored at one and three-month intervals
2
Change in estimated glomerular filtration rate (eGFR) from baseline
Timeframe: Outcomes monitored at one and three-month intervals