Alcoholic Liver Disease
Conditions
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.
Interventions
DRUGLivitol-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.
Sponsors
Composite Interceptive Med Science
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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 ALP(Alkaline Phosphatase) | 3 months | The above mentioned test will be measured with panel of Liver function test at central laboratory. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in maddrey discriminant function(DF) | 3 months | — |
| Change in radiological response | 3 months | The degree of fatty infiltration will be assessed by ultrasound. |
Countries
India
Contacts
Primary ContactAlben Sigamani, MD
Backup ContactSanjaya Chauhan, PharmD
Outcome results
None listed