The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules

NCT05042245 | Completed Phase 4

• 1 other identifier: XH-19-005
• Study Type: interventional
• Target: 237
• Locations: 1 country
• Sites: 1

Brief 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. The hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.

Conditions

Non-alcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

• The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%

  Assessed at 24 weeks

Secondary Outcomes (2)

• The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH

  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%

  Assessed at 4 weeks, 12 weeks, and 24 weeks

Other Outcomes (4)

• The changed amount of blood ammonia

  Assessed at 4 weeks, 12 weeks, and 24 weeks

• The changed amount of body fat

  Assessed at 4 weeks, 12 weeks, and 24 weeks

• The changed amount of body fat proportion

  Assessed at 4 weeks, 12 weeks, and 24 weeks

Study Arms (2)

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).

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) .

Drug: Silymarin capsule; Drug: Ornithine aspartate granule simulant

Interventions

Silymarin capsule DRUG

Silymarin capsules in the active comparator arm.

silymarin capsule group

Silymarin capsule simulant DRUG

Silymarin capsule simulant in the experimental arm.

ornithine aspartate granule group

Ornithine aspartate granule simulant DRUG

Ornithine aspartate granule simulant in the active comparator arm.

silymarin capsule group

Ornithine aspartate granule DRUG

Ornithine aspartate granules in the experimental arm.

ornithine aspartate granule group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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;
• \. During previous one month, serum ALT level was higher than 1.5 times the upper limit of normal.
• \. BMI is not more than 30 kg/m2.
• \. Voluntary to participate in the research and signed a written informed consent to comply with the trial protocol.

You may not qualify if:

• \. 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);
• \. Hepatic or extrahepatic malignant tumors;
• \. Severe heart failure or renal failure (serum creatinine \> 3mg/100mL);
• \. Allergic constitution, or allergic to amino acid drugs or to ornithine aspartate and its constituents or to silymarin;
• \. ALT or γ-glutamyl transpeptidase (γ-GT) are greater than 5 times the upper limit of normal, or total bilirubin (TBIL) \> 51 umol/L.;
• \. Confirmed liver cirrhosis or Fibroscan test showed E value \> 12.5 kilopascal (KPa);
• \. Triglyceride \> 5.6mmol/L;
• \. Diabetes diagnosed for more than 5 years, combined with current insulin therapy or taking hypoglycemic drugs with poorly controlled condition (HbA1c \> 9%).
• \. Women who are pregnant, nursing or preparing for pregnancy;
• \. Suspected or confirmed excessive drinking (equivalent alcohol amount: male, \> 40g/d; female, \> 20g/d), or history of drug abuse;
• \. 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;
• \. Taking weight-loss drugs or receiving weight-loss treatment;
• \. Situations of inappropriate participation judged by researchers.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Beijing Ditan Hospital: collaborator
• Beijing YouAn Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: collaborator

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Silymarin

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Flavonolignans; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Jian G Fan, PHD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 13, 2021
• Study Start: July 23, 2019
• Primary Completion: December 18, 2022
• Study Completion: December 20, 2022
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)