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
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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/m
- •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.
Arms & Interventions
silymarin capsule group
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) .
Intervention: Ornithine aspartate granule simulant (Drug)
ornithine aspartate granule group
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).
Intervention: Ornithine aspartate granule (Drug)
ornithine aspartate granule group
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).
Intervention: Silymarin capsule simulant (Drug)
silymarin capsule group
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) .
Intervention: Silymarin capsule (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Jiangao Fan
Professor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine