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

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ornithine aspartate granule
Silymarin capsule
Silymarin capsule simulant
Ornithine aspartate granule simulant
Sponsored by
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xinhua Hospital, Shanghai Jiao Tong University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ornithine aspartate granule group

silymarin capsule group

Arm Description

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).

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) .

Outcomes

Primary Outcome Measures

The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%

Secondary Outcome Measures

The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%

Full Information

First Posted
August 24, 2021
Last Updated
September 14, 2021
Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Beijing Ditan Hospital, Beijing YouAn Hospital, Wuhan Union Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT05042245
Brief Title
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

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2019 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Collaborators
First Affiliated Hospital, Sun Yat-Sen University, Beijing Ditan Hospital, Beijing YouAn Hospital, Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ornithine aspartate granule group
Arm Type
Experimental
Arm Description
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).
Arm Title
silymarin capsule group
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ornithine aspartate granule
Intervention Description
Ornithine aspartate granules in the experimental arm.
Intervention Type
Drug
Intervention Name(s)
Silymarin capsule
Intervention Description
Silymarin capsules in the active comparator arm.
Intervention Type
Drug
Intervention Name(s)
Silymarin capsule simulant
Intervention Description
Silymarin capsule simulant in the experimental arm.
Intervention Type
Drug
Intervention Name(s)
Ornithine aspartate granule simulant
Intervention Description
Ornithine aspartate granule simulant in the active comparator arm.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks
Title
The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks
Other Pre-specified Outcome Measures:
Title
The changed amount of blood ammonia
Description
An exploratory indicator
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks
Title
The changed amount of body fat
Description
An exploratory indicator of body composition analysis
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks
Title
The changed amount of body fat proportion
Description
An exploratory indicator of body composition analysis
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks
Title
The changed amount of muscle mass
Description
An exploratory indicator of body composition analysis
Time Frame
Assessed at 4 weeks, 12 weeks, and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jian G Fan, PHD
Email
fattyliver2004@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian G Fan, PHD
Organizational Affiliation
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200092
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jian G Fan, PHD
Email
fattyliver2004@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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