Type 2 DiabetesNCT07871370
Silymarin Effects on Fatty Liver in Type 2 Diabetics
A study testing Silymarin (Silybum marianum) in people with Type 2 Diabetes and Fatty Liver, run by University of Mosul at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes, Fatty Liver
- What is being tested?
- Silymarin (Silybum marianum)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIraq
- Study dates
- 2 Jan 2024to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Silymarin (Milk Thistle) on Hepatic Fibrosis, Glycemic Control and Biochemical Parameters in Type 2 Diabetic Patients
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.
- Conditions
- Type 2 Diabetes, Fatty Liver
- Being tested
- Silymarin (Silybum marianum)
- Keywords
- Diabetes, Silymarin, Fatty Liver, Milk Thistle, metabolic parameters
- Medical subject headings
- Diabetes Mellitus, Type 2, Fatty Liver, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silymarin (Silybum marianum)Dietary supplement
Also called Milk Thistle
Participants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months. Receives: Dietary Supplement: Silymarin (Silybum marianum) |
| Standard Control Group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of treatment at 9 months.
Secondary outcomes (1)
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).
Measured: From enrollment to end of treatment at 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Jan 2024
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mosul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Satea Mahmood, University of Mosul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871370
- Sponsor's protocol ID
- HF-2026-0201.
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Silymarin (Milk Thistle) on Hepatic Fibrosis, Glycemic Control and Biochemical Parameters in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT07871370
- Acronym / sponsor ID
- HF-2026-0201.
- Conditions
- Type 2 Diabetes, Fatty Liver
- Keywords
- Diabetes, Silymarin, Fatty Liver, Milk Thistle, metabolic parameters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MosulUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Dietary Supplement: Silymarin (Silybum marianum)Participants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months. |
| Standard Control Group | No intervention | –No intervention |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silymarin (Silybum marianum)Also: Milk ThistleParticipants received a daily oral dose of 480 mg of silymarin as an add on supplementation for 9 months. | Dietary supplement | Intervention Group |
Primary outcome
Change in Liver Steatosis and Fibrosis Scores
Time frame: From enrollment to end of treatment at 9 months.
Measured using FibroScan (transient elastography) to assess changes in liver fat content (Controlled Attenuation Parameter / CAP) and liver stiffness/fibrosis stage.
1 secondary outcome
Change in Glycemic, Hepatic, Lipid, and Renal Laboratory Parameters
Time frame: From enrollment to end of treatment at 9 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silymarin (Silybum marianum) in people with Type 2 Diabetes and Fatty Liver, run by University of Mosul at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Liver Steatosis and Fibrosis Scores (time frame: From enrollment to end of treatment at 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.