Health Condition 1: K716- Toxic liver disease with hepatitis, not elsewhere classified
Conditions
Interventions
Intervention1: Liv.52 GNX: 1 Tablets twice a day, Oral,for 6 months
Control Intervention1: Liv.52 DS: 1 Tablets twice a day, Oral,for 6 months
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: Newly diagnosed cases of tuberculosis,Patients on ATT presenting with symptoms of hepatotoxicity like anorexia, abdominal discomfort and pain in right hypochondrium,with elevated levels of liver enzymes >= ULN SGPT-70/L, SGOT-70/L and Bilirubin 3 mg/dL. Patients receiving antitubercular drugs which have a potential to cause hepatotoxicity like Isoniazid, Rifampicin, pyrazinamide in the first 2 months of Intensive regimen (2HRZE phase). Patients who are on ATT treatment with liver abnormalities like cirrhosis of liver, Alcoholic liver disease, hepatomegaly and alcoholism. Has not participated in a similar investigation in past four weeks,Willing to give a written and video informed consent and follow the study protocol.
Exclusion criteria
Exclusion criteria: Severe metabolic disorders, history or present condition of allergic response to similar Pharmaceutical products, its components or ingredients in the test products, Genetic and endocrinal disorders. Has participated in a similar clinical investigation or used a similar product in the past four weeks, Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and liver function tests to normal limits.Timepoint: Visit 0 At entry visit, baseline Visit 1 At the end of 60 days (2 months) Visit 2 At the end of 120 days (4 months) Visit 3 (End of the study) At the end of 180 days (6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation and reporting of adverse effects to investigational products.Timepoint: Visit 0 At entry visit, baseline Visit 1 At the end of 60 days (2 months) Visit 2 At the end of 120 days (4 months) Visit 3 (End of the study) At the end of 180 days (6 months) | — |
Countries
India
Contacts
Public ContactDr Deba prasad
Gopabandhu Ayurveda Mahavidyalaya
Outcome results
None listed