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Fatty liver drug showdown: ornithine aspartate vs silymarin

NCT ID NCT05042245

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

237 people

The number who actually took part.

Started

Jul 2019

Finished

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

18 to 65 years

Sex

Anyone

Healthy volunteers

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

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

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200092, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.