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CLEARLIV Tablet in Alcoholic Liver Disease Patients.

A Randomized Clinical End Point Study To Evaluate The Safety And Efficacy Of CLEARLIV Tablets In Patients With Alcoholic Liver Disease. - ALD

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012644
Enrollment
24
Registered
2018-03-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Alcoholic Liver Disease patients

Interventions

Intervention1: Clearliv tablets: Clearliv Tablet is a research product developed by Apex laboratories limited, for hepatoprotection. The formulation has been validated scientifically and traditional c

Sponsors

Apex Laboratories
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Chronic alcohol intake patients 2.Serum AST &ALT is typically elevated to a level of 2â??6 times the upper limits of the normal. 3.Negative pregnancy test for women in reproductive age (up to two weeks prior to the study) 4.Negative for hepatitis B and C

Exclusion criteria

Exclusion criteria: 1.Patients who have liver disease with the cause different from that of alcohol induced liver disease. 2.Drug dependence 3.A known hypersensitivity or allergy to any component of the drugs evaluated in the study.

Design outcomes

Primary

MeasureTime frame
1.Change in AST,ALT and bilirubin values from baseline to 4 and 8 weeks as compared to Silymarin group. Timepoint: 4 th and 8th week

Secondary

MeasureTime frame
1.Number of Participants with Adverse Events (Safety) 2.To evaluate ALT normalization 3.To evaluate AST normalization Timepoint: 4th and 8th week

Countries

India

Contacts

Public ContactDr Ramesh Kannan

PM Medical Centre

srkguruvarshan@gmail.com9677786449

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026