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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-26

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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) .

Group Type ACTIVE_COMPARATOR

Silymarin capsule

Intervention Type DRUG

Silymarin capsules in the active comparator arm.

Ornithine aspartate granule simulant

Intervention Type DRUG

Ornithine aspartate granule simulant in the active comparator arm.

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).

Group Type EXPERIMENTAL

Ornithine aspartate granule

Intervention Type DRUG

Ornithine aspartate granules in the experimental arm.

Silymarin capsule simulant

Intervention Type DRUG

Silymarin capsule simulant in the experimental arm.

Interventions

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Ornithine aspartate granule

Ornithine aspartate granules in the experimental arm.

Intervention Type DRUG

Silymarin capsule

Silymarin capsules in the active comparator arm.

Intervention Type DRUG

Silymarin capsule simulant

Silymarin capsule simulant in the experimental arm.

Intervention Type DRUG

Ornithine aspartate granule simulant

Ornithine aspartate granule simulant in the active comparator arm.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No