Non-alcoholic Fatty Liver Disease
Conditions
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.
Interventions
DRUGOrnithine aspartate granule
Ornithine aspartate granules in the experimental arm.
DRUGSilymarin capsule
Silymarin capsules in the active comparator arm.
DRUGSilymarin capsule simulant
Silymarin capsule simulant in the experimental arm.
DRUGOrnithine aspartate granule simulant
Ornithine aspartate granule simulant in the active comparator arm.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
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 design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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/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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10% | Assessed at 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORJian G Fan, PHD
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed