Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
- Registration Number
- NCT03503708
- Lead Sponsor
- Composite Interceptive Med Science
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Group Livitol-70 All the eligible participants will receive Livitol-17 capsules. It consist of 390 mg of whole herbs and extract of Phyllanthus niruri (Bhumyamalaki), Boerhaavia diffusa (Punarnava) and Picroorrhiza kurroa (Katuki).
- Primary Outcome Measures
Name Time Method Change from baseline in ALT(Alanine Aminotransferase) 3 months The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in AST(Aspartate Aminotransferase) 3 months The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALP(Alkaline Phosphatase) 3 months The above mentioned test will be measured with panel of Liver function test at central laboratory.
Number of Subject with adverse events 3 months Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.
Change from baseline in GGT(Gamma Glutamyl Transferase) 3 months The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in serum total bilirubin 3 months The above mentioned test will be measured with panel of Liver function test at central laboratory.
- Secondary Outcome Measures
Name Time Method Change in radiological response 3 months The degree of fatty infiltration will be assessed by ultrasound.
Change in maddrey discriminant function(DF) 3 months
Trial Locations
- Locations (1)
Mazumdar Shaw Medical Centre
🇮🇳Bangalore, Karnataka, India