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

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ClinicalTrials.gov Identifier: NCT03503708
Recruitment Status : Not yet recruiting
First Posted : April 20, 2018
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alcoholic Liver Disease Drug: Livitol-70 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
Estimated Study Start Date : May 30, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : November 30, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Arm Intervention/treatment
Experimental: Intervention Group
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).
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503708


Contacts
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Contact: Alben Sigamani, MD 8884431444 alben.sigamani.dr@narayanahealth.org
Contact: Sanjaya Chauhan, PharmD 9611252350 drsanjayachauhan49@gmail.com

Locations
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India
Mazumdar Shaw Medical Centre Not yet recruiting
Bangalore, Karnataka, India, 560099
Contact: Alben Sigamani, MD    8884431444    alben.sigamani.dr@narayanahealth.org   
Contact: Sanjaya Chauhan, PharmD    9611252350 ext Chauhan    drsanjayachauhan49@gmail.com   
Sponsors and Collaborators
Composite Interceptive Med Science
Investigators
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Principal Investigator: Alben Sigamani, MD Narayana Hrudayalaya Hospital
Study Chair: Sanjaya Chauhan, PharmD Composite Interceptive Med Science

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Responsible Party: Composite Interceptive Med Science
ClinicalTrials.gov Identifier: NCT03503708     History of Changes
Other Study ID Numbers: OI-009-2018
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Liver Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders