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

Non-alcoholic Fatty Liver Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042245
• Other study ID #: XH-19-005
• Status: Recruiting
• Phase: Phase 4
• Start date: April 26, 2019
• Est. completion date: June 2022

Study information

• Verified date: September 2021
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Jian G Fan, PHD
• Email: fattyliver2004[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 ?-glutamyl transpeptidase (?-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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Intervention

Drug:
• Ornithine aspartate granule
Ornithine aspartate granules in the experimental arm.
• Silymarin capsule
Silymarin capsules in the active comparator arm.
• Silymarin capsule simulant
Silymarin capsule simulant in the experimental arm.
• Ornithine aspartate granule simulant
Ornithine aspartate granule simulant in the active comparator arm.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai

Sponsors (5)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Beijing Ditan Hospital, Beijing YouAn Hospital, First Affiliated Hospital, Sun Yat-Sen University, Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The changed amount of blood ammonia	An exploratory indicator	Assessed at 4 weeks, 12 weeks, and 24 weeks
Other	The changed amount of body fat	An exploratory indicator of body composition analysis	Assessed at 4 weeks, 12 weeks, and 24 weeks
Other	The changed amount of body fat proportion	An exploratory indicator of body composition analysis	Assessed at 4 weeks, 12 weeks, and 24 weeks
Other	The changed amount of muscle mass	An exploratory indicator of body composition analysis	Assessed at 4 weeks, 12 weeks, and 24 weeks
Primary	The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%		Assessed at 24 weeks
Secondary	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
Secondary	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