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

Phase 4

• Conditions: Non-alcoholic Fatty Liver Disease
• Interventions: Drug: Ornithine aspartate granule; Drug: Silymarin capsule; Drug: Silymarin capsule simulant; Drug: Ornithine aspartate granule simulant

• Registration Number: NCT05042245
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-26
• Study First Submitted: 2021-08-24
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-03
• Study First Posted: 2021-09-13
• Last Update Submitted: 2021-09-14
• Last Update Posted: 2021-09-21
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ornithine aspartate granule group	Ornithine aspartate granule	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).
ornithine aspartate granule group	Silymarin capsule simulant	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).
silymarin capsule group	Silymarin capsule	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) .
silymarin capsule group	Ornithine aspartate granule simulant	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) .

Primary Outcome Measures

Name	Time	Method
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%	Assessed at 24 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China