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NCT Number: NCT03503708

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

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.

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Key information

Conditions

Alcoholic Liver Disease Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Liver Diseases Liver Diseases, Alcoholic Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Livitol-70

Drug

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 outcomes

  1. Change from baseline in AST(Aspartate Aminotransferase)

    Time frame: 3 months

    The above mentioned test will be measured with panel of Liver function test at central laboratory.

  2. Change from baseline in ALT(Alanine Aminotransferase)

    Time frame: 3 months

    The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3. Change from baseline in ALP(Alkaline Phosphatase)

    Time frame: 3 months

    The above mentioned test will be measured with panel of Liver function test at central laboratory.

  4. Change from baseline in GGT(Gamma Glutamyl Transferase)

    Time frame: 3 months

    The above mentioned test will be measured with panel of Liver function test at central laboratory.

  5. Change from baseline in serum total bilirubin

    Time frame: 3 months

    The above mentioned test will be measured with panel of Liver function test at central laboratory.

  6. Number of Subject with adverse events

    Time frame: 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.

Secondary outcomes

  1. Change in radiological response

    Time frame: 3 months

    The degree of fatty infiltration will be assessed by ultrasound.

  2. Change in maddrey discriminant function(DF)

    Time frame: 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Alben Sigamani, MD

CONTACT

[email protected]

8884431444

Sanjaya Chauhan, PharmD

CONTACT

[email protected]

9611252350

Sponsors and collaborators

Lead sponsor

Composite Interceptive Med Science

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2028
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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