Clinical trial NCT03503708: Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
Official title: Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcoholic Liver Disease
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2018-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


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.

Primary outcomes:
measure: Change from baseline in AST(Aspartate Aminotransferase)
timeFrame: 3 months
measure: Change from baseline in ALT(Alanine Aminotransferase)
timeFrame: 3 months
measure: Change from baseline in ALP(Alkaline Phosphatase)
timeFrame: 3 months
measure: Change from baseline in GGT(Gamma Glutamyl Transferase)
timeFrame: 3 months
measure: Change from baseline in serum total bilirubin
timeFrame: 3 months
measure: Number of Subject with adverse events
timeFrame: 3 months
Secondary outcomes:
measure: Change in radiological response
timeFrame: 3 months
measure: Change in maddrey discriminant function(DF)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical Centre
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Alben Sigamani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Composite Interceptive Med Science
name: Sanjaya Chauhan, PharmD
role: STUDY_CHAIR
References: