Clinical Study to evaluate the safety and efficacy of Livercure tablets on patients with Liver Cirrhosis

Jammi Pharmaceuticals Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

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•1 Patients aged between 18 to 70 years with a confirmed diagnosis of liver cirrhosis (diagnosed by clinical, biochemical, sonographic or histological evidence of cirrhosis and portal hypertension).
•2 Evidence of decompensated liver disease at screening (e.g., Child class B or C, Child-Pugh scores of =7).
•3 MELD scores of at least 10 (UNOS Meld calculator).
•4 AFP Level < 400ng/ml.
•5 Signed informed consent.
•6 Excessive consumption of alcohol ( >30 gm of absolute alcohol/day) use in the last 3 months before screening can be included
•7 Positive HBsAg or antibodies to HCV

•1 Patients likely to undergo liver transplantation during the duration of the study.
•2 Presence of advanced hepatic encephalopathy Grades 3 and 4 at the time of screening- Annexure V.
•3 Evidences of autoimmune liver disease- ANA or Anti-LKM positivity.
•4 Platelet count < 30,000/mm3.
•5 Serum Sodium <129mEq/L.
•6 Serum Creatinine > 2 mg/dl.
•7 Hepatocellular carcinoma or other malignancies
•8 Active infectious disease.
•9 Presence of severe underlying cardiac, pulmonary or renal disease.
•10 Positive antibodies to HIV
•11 Pregnancy or lactating women
•12 Actively participating in in other clinical trial or has participated in a clinical trial within the last 30 days.
•13 Unwilling/unable to sign the informed consent
•14 Any condition in the opinion of the investigator that may compromise the safety of the patient by participating in this study.

发起方

Jammi Pharmaceuticals Pvt Ltd