Health Condition 1: K709- Alcoholic liver disease, unspecified
Conditions
Interventions
Intervention1: Liv.52 GNX tablet: 1 Tablets twice a day for 8 weeks
Control Intervention1: Liv.52 DS: 1 Tablets twice a day for 8 weeks
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1 Preferably Male patients aged more than 18 years to 70 years with diagnosis of symptomatic Alcoholic liver disease 2 Patients who are presenting with one or more altered liver function parameters with a minimum consumption of alcohol for 3 times a week. 3 Alcoholic, for at least a minimum period of 1 year. 4 Clinically presenting with one or more clinical symptoms of Alcoholic liver disease like abdominal discomfort, anorexia, weakness, easy fatiguability etc. 5 Willing to sign inform consent form and comply with the study procedure.
Exclusion criteria
Exclusion criteria: 1 Pregnant women, patients with severe hepatitis, patients with malignant jaundice 2 Patients with other causes for acute hepatitis (drug-induced) 3 Patients unwilling to provide informed consent or abide by the requirements of the study 4 A known history or present condition of allergic response to any of the herbs or drugs 5 Pre-existing systemic disease necessitating long-term medications. 6 Genetic and endocrinal disorders. 7 Has participated in a similar clinical investigation in the past four weeks. 8 Has used a similar product in the past four weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Liver function parameters due to alcoholism. Improvement of Clinical Parameters due to Alcoholic liver disease Timepoint: Visit 0- At entry visit, baseline Visit 1- At the end of Week 4 Visit 2- At the end of Week 8 (End of the treatment) | — |
Secondary
| Measure | Time frame |
|---|---|
| To identify the safety of incidence of adverse drug reaction. To evaluate improvement in health related quality of life.Timepoint: Visit 0- At entry visit, baseline Visit 1- At the end of Week 4 Visit 2- At the end of Week 8 (End of the treatment) | — |
Countries
India
Contacts
Public ContactDr D Gautam
R G Kar Medical College
Outcome results
None listed