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Clinical Trials/CTRI/2018/05/013865
CTRI/2018/05/013865Recruiting未知

Antioxidant for improvement of hepatic function in patients with Alcohol Liver Disease without cirrhosis: Non-randomized Interventional Cohort Study

Composite Interceptive MedScience Laboratories Private Limited0 sites0 target enrollmentStarted: TBDLast updated:

Trial Snapshot

Phase
未知
Status
Recruiting
Sponsor

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Inclusion Criteria

  • Adults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:
  • 1. Chronic alcohol intake, Identified with AUDIT Questionnaire (A total sum of AUDIT >= 8 for men up to age 60, or >=4 for women, and men over age 60 is considered a positive screening test.)
  • 2. Active alcohol use until 4 weeks prior to presentation
  • 3. ALT and AST elevated >1.5 times the upper limit of normal
  • 4. Over 1.5 ratio of AST to ALT
  • 5. Maddrey Discriminant function(DF) less than 30

Exclusion Criteria

  • Any one of the following
  • 1.Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
  • 2. Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
  • 3. Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilsons disease
  • 4. Participants with active viral hepatitis
  • 5. Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
  • 6. Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
  • 7. Pregnant, attempting to conceive, or lactating women
  • 8. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

Investigators

Sponsor
Composite Interceptive MedScience Laboratories Private Limited

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