Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Livitol-70.
- Who it may be relevant to
- Registry conditions: Alcoholic Liver Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
Overview
Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.
Interventions
- Drug Livitol-70
Livitol-17 detoxifies, purifies and rejuvenates liver, kidney and spleen. Participants will be given the intervention in two bottles at each visit. Participant will be instructed to take two capsule twice daily at a fixed time in the day.
Primary outcome measures
- Change from baseline in AST(Aspartate Aminotransferase) [Time frame: 3 months]
- Change from baseline in ALT(Alanine Aminotransferase) [Time frame: 3 months]
- Change from baseline in ALP(Alkaline Phosphatase) [Time frame: 3 months]
- Change from baseline in GGT(Gamma Glutamyl Transferase) [Time frame: 3 months]
- Change from baseline in serum total bilirubin [Time frame: 3 months]
- Number of Subject with adverse events [Time frame: 3 months]
Secondary outcome measures (2)
- Change in radiological response [Time frame: 3 months]
- Change in maddrey discriminant function(DF) [Time frame: 3 months]
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:
- Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire
- Active alcohol use until 4 weeks prior to presentation
- ALT and AST elevated >1.5 times the upper limit of normal
- Over 1.5 ratio of AST to ALT
- Maddrey Discriminant function(DF) less than 30
Exclusion criteria
- Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months
- Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)
- Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease
- Participants with active viral hepatitis
- Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry
- Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
- Pregnant, attempting to conceive, or lactating women
- Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
India · 1 center
- Mazumdar Shaw Medical Centre — Bangalore
Identifiers
NCT: NCT03503708 · OI-009-2018