Fatty liver drug showdown: ornithine aspartate vs silymarin
NCT ID NCT05042245
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether ornithine aspartate granules work better than silymarin capsules for non-alcoholic fatty liver disease (NAFLD). 237 adults with NAFLD and elevated liver enzymes took one of the two treatments for a period. The main goal was to see if liver fat levels improved. The trial is complete, and results will show if ornithine aspartate is a good alternative.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ornithine aspartate granules
- What this could lead to
- If it works, this could offer a new treatment option for non-alcoholic fatty liver disease that is as good as or better than silymarin.
- What could go wrong
- This is a Phase 4 trial comparing two existing drugs, so no major breakthrough is expected. The primary outcome is a liver fat measurement, not a cure, and results may not apply to everyone with NAFLD.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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237 people
The number who actually took part.
- Started
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Jul 2019
- Finished
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Dec 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 1\. Consistent with NAFLD diagnosis criteria, and during previous one month, the B-mode ultrasonography showed diffuse fatty liver and Fibroscan test showed that CAP value \> 248 db/m; * 2\. During previous one month, serum ALT level was higher than 1.5 times the upper limit of normal. * 3\. BMI is not more than 30 kg/m2. * 4\. Voluntary to participate in the research and signed a written informed consent to comply with the trial protocol. Exclusion Criteria: * 1\. Hereditary metabolic or autoimmune liver disease, hepatotropic and non-hepatotropic virus infection, drug/toxic/alcoholic/biliary liver injury, or any end-stage liver disease; fatty liver disease caused by one of the following reasons: total parenteral nutrition, inflammatory bowel disease, hypothyroidism, Cushing's syndrome, beta-lipoprotein deficiency and some insulin resistance (IR) related syndromes (lipid atrophic diabetes, Mauriac syndrome); * 2\. Hepatic or extrahepatic malignant tumors; * 3\. Severe heart failure or renal failure (serum creatinine \> 3mg/100mL); * 4\. Allergic constitution, or allergic to amino acid drugs or to ornithine aspartate and its constituents or to silymarin; * 5\. ALT or γ-glutamyl transpeptidase (γ-GT) are greater than 5 times the upper limit of normal, or total bilirubin (TBIL) \> 51 umol/L.; * 6\. Confirmed liver cirrhosis or Fibroscan test showed E value \> 12.5 kilopascal (KPa); * 7\. Triglyceride \> 5.6mmol/L; * 8\. Diabetes diagnosed for more than 5 years, combined with current insulin therapy or taking hypoglycemic drugs with poorly controlled condition (HbA1c \> 9%). * 9\. Women who are pregnant, nursing or preparing for pregnancy; * 10\. Suspected or confirmed excessive drinking (equivalent alcohol amount: male, \> 40g/d; female, \> 20g/d), or history of drug abuse; * 11\. Combined use of drugs with liver protection and anti-inflammatory effects, as well as any Chinese patent medicine, Chinese herbal medicine, or health products that may have liver protection or liver damage effects; * 12\. Taking weight-loss drugs or receiving weight-loss treatment; * 13\. Situations of inappropriate participation judged by researchers.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092, China
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Other studies related to the condition(s) this trial covers.
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