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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorComposite Interceptive Med Science

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in AST(Aspartate Aminotransferase)

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

Time frame
3 months
2

Change from baseline in ALT(Alanine Aminotransferase)

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

Time frame
3 months
3

Change from baseline in ALP(Alkaline Phosphatase)

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

Time frame
3 months
4

Change from baseline in GGT(Gamma Glutamyl Transferase)

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

Time frame
3 months

Secondary outcomes

1

Change in radiological response

The degree of fatty infiltration will be assessed by ultrasound.

Time frame
3 months
2

Change in maddrey discriminant function(DF)

Time frame
3 months

Other outcomes

Sponsors and contacts

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