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Treatment, Research and Production Company of The Mong-Em, Mongolia
Title: THE RESULT OF CLINICAL TRIAL FOR THE NEW LONAL DRUG FOR HEPATOPROTECTIVE EFFECT IN PATIENT WITH DRUG INDUCED STEATOSIS: A Randomized Placebo-Controlled Double Blind Clinical Trail
Abstract

The aim of the our clinical trial was to determine hepatoprotective effect of the new Lonal drug in patient with drug induced steatosis. The research was considered such as clinical trial guideline for new drug issued by the World Health Organization’s "Good Clinical Practice”. Based on permission given by Biomedical Ethical Community of the Health Ministry of Mongolia approved diagnosis patient with drug induced steatosis. The our research design is Randomized Placebo-Controlled, Double Blind Clinical Trial. Lonal drug significant decreases hepatocellular and cholestatic injury. The Lonal drug was taken during 21 days and comparing the some results of metabolic syndrome before and after treatment, reduces TG (p=0,03). The participants have taken the fibroscan and liver biopsy. That was compared to determine before and after treatment such as steatosis and fibrosis degree of participants liver. Before treatment degree of steatosis was S3, after treatment it was dropped S2 (p <0.05). And before treatment, such as fibrosis degree F1-2, after treatment it was decreased F0 (p<0.05). New Lonal drug is reducing hepatocellular injury, cholestatic injury and some criteria of the metabolic syndrome in patient drug induced steatosis. Also new Lonal drug reduces activition of inflammation, decreases the degree of liver steatosis fibrosis validated by liver biopsy and fibroscan.

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