Clinical trial NCT05042245: The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital, Sun Yat-Sen University
name: Beijing Ditan Hospital
name: Beijing YouAn Hospital
name: Wuhan Union Hospital, China
First posted: 2021-09-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%
timeFrame: Assessed at 24 weeks
Secondary outcomes:
measure: The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
measure: The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
Other outcomes:
measure: The changed amount of blood ammonia
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
measure: The changed amount of body fat
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
measure: The changed amount of body fat proportion
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
measure: The changed amount of muscle mass
timeFrame: Assessed at 4 weeks, 12 weeks, and 24 weeks
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: Jian G Fan, PHD
role: PRINCIPAL_INVESTIGATOR
References: