Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease

Alcoholic Liver Disease Clinical Trial

Official title:

Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03503708
• Other study ID #: OI-009-2018
• Status: Not yet recruiting
• Phase: N/A
• First received: April 11, 2018
• Last updated: April 19, 2018
• Start date: May 30, 2018
• Est. completion date: November 30, 2028

Study information

• Verified date: April 2018
• Source: Organic India
• Contact: Alben Sigamani, MD
• Phone: 8884431444
• Email: alben.sigamani.dr[@]narayanahealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 30, 2028
• Est. primary completion date: October 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcoholic Liver Disease
• Liver Diseases
• Liver Diseases, Alcoholic

Intervention

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.

Locations

Country	Name	City	State
India	Mazumdar Shaw Medical Centre	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Organic India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in AST(Aspartate Aminotransferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Primary	Change from baseline in ALT(Alanine Aminotransferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Primary	Change from baseline in ALP(Alkaline Phosphatase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Primary	Change from baseline in GGT(Gamma Glutamyl Transferase)	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Primary	Change from baseline in serum total bilirubin	The above mentioned test will be measured with panel of Liver function test at central laboratory.	3 months
Primary	Number of Subject with adverse events	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.	3 months
Secondary	Change in radiological response	The degree of fatty infiltration will be assessed by ultrasound.	3 months
Secondary	Change in maddrey discriminant function(DF)		3 months