Non-alcoholic Fatty Liver DiseasePhase 4NCT05042245
The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules
A Phase 4 study testing Ornithine aspartate granule, Silymarin capsule and Silymarin capsule simulant in people with Non-alcoholic Fatty Liver Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- Ornithine aspartate granule, Silymarin capsule and Silymarin capsule simulant
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 237 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2019to 20 Dec 2022
- Phase
- Phase 4
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: The Efficacy and Safety of Ornithine Aspartic Acid Granules in Non-Alcoholic Fatty Liver Disease Against Silymarin Capsules: a Randomized, Double-Blind, Multicenter Clinical Trial
This is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. The hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- Ornithine aspartate granule, Silymarin capsule, Silymarin capsule simulant, Ornithine aspartate granule simulant
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ornithine aspartate granuleDrug
Ornithine aspartate granules in the experimental arm.
Silymarin capsuleDrug
Silymarin capsules in the active comparator arm.
Silymarin capsule simulantDrug
Silymarin capsule simulant in the experimental arm.
Ornithine aspartate granule simulantDrug
Ornithine aspartate granule simulant in the active comparator arm.
| Study group | Role | What they receive |
|---|---|---|
| ornithine aspartate granule group | Experimental | Patients in this group will be given aspartate ornithine granules (3 g po tid, after three meals) and silymarin capsule simulant (140 mg po bid, before breakfast and dinner). Receives: Drug: Ornithine aspartate granule; Drug: Silymarin capsule simulant |
| silymarin capsule group | Active comparator | Patients in this group will be given silymarin capsule (140 mg po bid, before breakfast and dinner) and aspartate ornithine granules simulant (3 g po tid, after three meals) . Receives: Drug: Silymarin capsule; Drug: Ornithine aspartate granule simulant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%
Measured: Assessed at 24 weeks
Secondary outcomes (2)
The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
Measured: Assessed at 4 weeks, 12 weeks, and 24 weeks
The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
Measured: Assessed at 4 weeks, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start23 Jul 2019
- Primary completion18 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Beijing Ditan Hospital, Beijing YouAn Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Responsible party
- Principal investigator, Jiangao Fan, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jian G Fan, PHD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042245
- Sponsor's protocol ID
- XH-19-005
- Status last verified
- Mar 2026
- First submitted
- 24 Aug 2021
- Last updated
- 16 Mar 2026
- Results posted
- 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 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Ornithine Aspartic Acid Granules in Non-Alcoholic Fatty Liver Disease Against Silymarin Capsules: a Randomized, Double-Blind, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05042245
- Acronym / sponsor ID
- XH-19-005
- Conditions
- Non-alcoholic Fatty Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Beijing Ditan Hospital, Beijing YouAn Hospital, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Study start
- 23 Jul 2019 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 13 Sep 2021 (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 is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. The hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ornithine aspartate granule group | Experimental | Drug: Ornithine aspartate granule, Drug: Silymarin capsule simulantPatients in this group will be given aspartate ornithine granules (3 g po tid, after three meals) and silymarin capsule simulant (140 mg po bid, before breakfast and dinner). |
| silymarin capsule group | Active comparator | Drug: Silymarin capsule, Drug: Ornithine aspartate granule simulantPatients in this group will be given silymarin capsule (140 mg po bid, before breakfast and dinner) and aspartate ornithine granules simulant (3 g po tid, after three meals) . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.;
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 |
|---|---|---|
| Ornithine aspartate granuleOrnithine aspartate granules in the experimental arm. | Drug | ornithine aspartate granule group |
| Silymarin capsuleSilymarin capsules in the active comparator arm. | Drug | silymarin capsule group |
| Silymarin capsule simulantSilymarin capsule simulant in the experimental arm. | Drug | ornithine aspartate granule group |
| Ornithine aspartate granule simulantOrnithine aspartate granule simulant in the active comparator arm. | Drug | silymarin capsule group |
Primary outcome
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%
Time frame: Assessed at 24 weeks
2 secondary outcomes
The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
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 16 Mar 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.
Jian G Fan, PHD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ornithine aspartate granule, Silymarin capsule and Silymarin capsule simulant in people with Non-alcoholic Fatty Liver Disease, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. 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 16 Mar 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10% (time frame: Assessed at 24 weeks). 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 16 Mar 2026.