Evaluation of safety and efficacy of Liv.52 GNX tablets in Anti tubercular therapy (ATT) induced hepatotoxicity; A randomized, comparator controlled clinical study

The Himalaya Drug Company0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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.

•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

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