An interventional study of Silymarin (Silybum marianum) in Type 2 Diabetes and Fatty Liver, sponsored by University of Mosul. Completed at 1 site in Iraq. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by University of Mosul · Not applicable, Interventional, and Treatment
This nine-month prospective clinical trial evaluated the effects of adding a daily oral dose of 480 mg of silymarin (milk thistle) to standard multi-drug therapy in 120 adult patients with Type 2 diabetes. Compared to the control group receiving standard care alone, participants taking silymarin showed significant reductions in liver enzymes (AST and ALT), improvements in their lipid profiles, and reduced liver fat (steatosis) confirmed via FibroScan imaging. While renal function remained stable and the supplement proved safe, silymarin did not lead to changes in overall liver fibrosis stages over the study duration. Ultimately, the trial demonstrates that silymarin can serve as a safe and effective adjunctive supplement to help manage hepatic steatosis and liver inflammation in patients with Type 2 diabetes.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's enrollment of 120 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of Mosul is the lead sponsor of 7 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: Type 2 Diabetes Patients who were on standard of care therapy consisting of: Metformin (2000 mg/day), Pioglitazone (30 mg/day) and Dapagliflozin (10 mg/day). Atorvastatin (20 mg/day) was added for patients 40 years old and above as per guidelines.
Exclusion Criteria: Patients with a known liver disease, Autoimmune diseases, type 1 diabetes mellitus, chronic kidney disease, pregnant or lactating ladies.
Participants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months.
Dietary Supplement: Silymarin (Silybum marianum)
No intervention
Participants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months.
Also known as: Milk Thistle
Change in Liver Steatosis and Fibrosis Scores
Measured using FibroScan (transient elastography) to assess changes in liver fat content (Controlled Attenuation Parameter / CAP) and liver stiffness/fibrosis stage.
Time frame: From enrollment to end of treatment at 9 months.
Change in Glycemic, Hepatic, Lipid, and Renal Laboratory Parameters
Assessed via blood laboratory testing to evaluate metabolic, liver, and kidney health. Specific parameters include glycated hemoglobin (HbA1c) for glycemic control; liver enzymes (ALT and AST) for hepatic function and inflammation; lipid panel (total cholesterol, triglycerides, HDL, and LDL) for lipid profile; and standard renal function tests (serum creatinine and blood urea nitrogen).
Time frame: From enrollment to end of treatment at 9 months.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Silymarin
University of Mosul