Evaluation of Safety and Efficacy of fixed dose combination of L-Ornithine-L-Aspartate 150 mg, Pancreatin IP 100mg enteric coated tablets as supportive and maintenance therapy in hepatitis: A Phase IV, Prospective, Open Label, Multi-centric, Single Arm, Clinical Study. - Hepamerz

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试验速览

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•1.Male/Female patients aged between 18-70 years with a clinical diagnosis of Hepatitis. The definition of Hepatitis is as mentioned below:
•Hepatitis is a term to describe inflammation (Swelling) in the liver. It can be caused due to viral infection or when liver is exposed to harmful substances such as alcohol. Hepatitis may occur with limited or no symptoms, but often leads to jaundice, anorexia (poor appetite) and malaise. Hepatitis is of two types: Acute and Chronic.
•2.Willingness to comply with the study schedule and procedures.
•3.Patient willing to give written informed consent prior to screening.

•1.Subject not willing to give written informed consent
•2.Severe renal insufficiency (A serum creatinine value over 1.5 mg/100 ml)
•3.Known hypersensitivity to any ingredient of the study drug.
•4.Acute or chronic liver failure
•5.Severe sepsis
•6.Advanced cardiac or pulmonary disease
•7.Neurologic disease (including head injury and drug intoxication).
•8.Pregnancy and Lactation.
•9.Female Subject not ready to use contraceptive measures during the trial period
•10.Subject with any condition which in opinion of the investigator makes the him/her unsuitable for inclusion.

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