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
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